 |
From
January 1 to December 31, 2000
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| Date
Filed
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| Docket
#
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| Name
of Petitioner/Subject Matter
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| Disposition
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| 01/04/2000
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| 2000P-0090
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| Pentech Pharmaceuticals
Inc/Determine Paxil Oral Capsules not withdrawn for safety reaso
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| 01/04/2000
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| 2000P-0091
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| Mitchall G Clark/ANDA
Suitability for Pamidronate Disodium Injection
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| 01/05/2000
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| 2000P-0092
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| GensiaSicor Pharmaceuticals/ANDA
Suitability for Thiotepa for Injection
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| 01/05/2000
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| 1999P-5589
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| Ethicon, Inc./Reclassification
of Absorbable Polydioxanone Surgical Suture
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| 01/05/2000
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| 1999V-5588
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| Gulf World, Inc./Laser
Light Show
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| 01/07/2000
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| 2000P-0110
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| Merck & Co. Inc./Add
finasteride to priority section of "the List"
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| 01/07/2000
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| 2000V-0111
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| Active Production
& Design/Laser Light Show (Mobolazer ML10-200,ML-300,ML10-300W,
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| 01/07/2000
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| 2000V-0112
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| Creative Artists Productions/Laser
Light SHow
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| 01/10/2000
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| 2000P-0117
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| Phoenix Scientific
Inc/ANADA Suitability for Lincomycin-Spectinomycin Water Soluble
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| 01/10/2000
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| 2000V-0135
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| Peppermill Casino/Variance
Laserium CSLP Projector
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| 01/11/2000
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| 2000P-0177
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| Robert Cohen/Request
that FDA not Approve Upjohn's Bovine Growth Hormone
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| 01/14/2000
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| 2000H-0211
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| Candyman Productions/Laser
Light Show
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| 01/14/2000
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| 2000V-0211
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| Candyman Productions/Laser
Light Show
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| 01/18/2000
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| 2000P-0219
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| Andrx Pharmaceuticals
Inc./Verapamil Hydrochloride Extended-Release Tablets
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| 01/27/2000
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| 2000V-0310
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| Museum of Science
and History/Laser Light Show
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| 01/27/2000
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| 2000V-0354
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| Chabot
Observatory & Science Center/Laser Light Show,Omniscan Laser
Projection System,2000 Serie
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| 01/28/2000
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| 2000P-0442
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| Ludlow Technical Products/Variance
from Perf Std for Electrode Lead Wires & Patient Ca
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| 01/31/2000
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| 2000A-0355
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| Marcode/Industrial
Marking Equipment Regarding Food Packing
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| 01/31/2000
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| 2000V-0353
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| The Shops at Sunset
Place/Laser Light Show
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| 02/01/2000
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| 2000P-0443
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| Pace Medical Inc/Exempt
Model 4220 Sterile Disposable Surgical Extension Cabe
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| 02/03/2000
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| 2000P-0425
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| Mead Johnson/To amend
21 CFR 107 Subpart B,labeling of infant formulas
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| 02/03/2000
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| 1999P-1589
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| Roxane Laboratories,
Inc/Stay effective date of approval for NDA 20-932 Roxicodone
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| 02/04/2000
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| 2000P-0444
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| Phoenix Scientific
Inc/ANADA Suitability for spectinomycin sterile solution
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| 02/04/2000
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| 1998N-0044
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| Nutraceutical Corporation/Effect
of dietary supplement on structure/function of body
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| 02/04/2000
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| 2000P-0499
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| Apotex Inc/Review/Act
on SKB '132 Form C & '423 Form A patent for NDA20
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| 02/07/2000
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| 2000N-0506
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| Grocery Manufacturers
of America/Safety Issues Associated With Dietary Supplements
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| 02/07/2000
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| 2000P-0497
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| Baxter Healthcare
Corporation/Exemption for the Baxter Volumetric Catheters
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| 02/07/2000
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| 2000P-0498
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| Baxter Healthcare
Corporation/Exempt Swan-Ganz Pacing Catheters and Probes
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| 02/07/2000
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| 2000V-0496
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| Advanced Lighting
& Production Services/Laser Light Show
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| 02/07/2000
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| 1998N-0044
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| Grocery Manufacturers
of America/Effect of dietary supplement on structure/function
of body
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| 02/07/2000
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| 1998N-0044
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| American Herbal Products
Association/Effect of dietary supplement on structure/function
of body
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| 02/07/2000
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| 1998N-0044
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| CRN & CHPA/Effect
of dietary supplement on structure/function of body
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| 02/07/2000
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| 1998N-0044
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| CRN & CHPA/Effect
of dietary supplement on structure/function of body
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| Date
Filed
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| Docket
#
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| Name
of Petitioner/Subject Matter
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| Disposition
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| 02/07/2000
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| 1998N-0044
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| McNeil Consumer Healthcare/Effect
of dietary supplement on structure/function of body
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| 02/10/2000
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| 2000V-0570
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| Pulse Laser Productions,LLC/Laser
Light Show
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| 02/10/2000
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| 2000V-0576
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| Event FX/Laser Light
Show Mobolazer ML10-250,ML10-300,ML10-300W,ML100
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| 02/11/2000
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| 2000P-0585
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| Lachman Consultant
Services, Inc./Prozac (Fluoxetine) Tablets Voluntarily Withdrawn
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| 02/11/2000
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| 2000P-0586
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| Natl Cheese Inst,Grocery
Mfg of America/Amend Pt 133.3 re:Milk and Nonfat Milk for use
in Standardiz
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| 02/12/2000
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| 2000P-0653
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| The James Madison
Project/Amend the product insert &/or label for Anthrax
Vaccive adso
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| 02/14/2000
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| 2000V-0654
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| Daddy Rocks, Inc/Mobolazer
ML10-200, ML10-300, ML10-300W, ML10-1000, ML10-2.5
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| 02/14/2000
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| 2000P-0596
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| Phoenix Scientific,
Inc,/ANADA consisting of different physical form of drug product
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| 02/15/2000
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| 2000V-0610
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| Insight Technology
Incorporated/Infrared Laser Aiming Light
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| 02/15/2000
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| 2000V-0611
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| Insight Technology
Incorporated/( Visible and IR Laser Aiming Module (LAM)
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| 02/15/2000
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| 2000V-0612
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| Insight Technology
Incorporated/Laser Aiming Device (AN/PAQ-4C)
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| 02/18/2000
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| 2000P-0685
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| National Yogurt Association/Revise
of Yogurt Standards
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| 02/22/2000
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| 2000V-0724
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| Mac Shane Laser Art
Productions/Laser Light Show, Laser Art Series
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| 02/24/2000
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| 2000P-0787
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| Abbott Laboratories/Electrode
Lead Wires/Patient Cables of 21 CFR part 898
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| 02/25/2000
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| 2000V-0791
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| Preston Productions
Inc./Laser Light Show
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| 02/28/2000
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| 2000P-0804
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| Thomas G. Crouthamel,
Sr./FD&C Yellow #5 & FD&C Blue #1 Labeling
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| 02/29/2000
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| 2000P-0788
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| Advanced Neuromodulation
Systems, Inc./Totally Implanted Spinal Cord Stimulator
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| 02/29/2000
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| 2000V-0808
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| Extreme Dome Enterainment/Laser
Light Show Entreme Dome- Centrar Starbeam CKO3
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| 03/01/2000
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| 2000P-0842
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| Thomas Blake, R.Ph./Zantac
75 Effervescent Tablets
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| 03/01/2000
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| 2000V-0877
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| Science Museum of
Minnesota/Laser Light Show
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| 03/01/2000
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| 2000V-0878
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| Franklin Institute
Science Museum/Laser Light Show
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| 03/02/2000
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| 2000V-0893
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| The Lions Share Inc/Laser
Light Show
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| 03/03/2000
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| 2000P-0913
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| McDermott, Will &
Emery/ANDA suitability for Albuterol Sulfate inhalation solution,
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| 03/07/2000
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| 2000V-0980
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| Carnegie Science Center/Laser
light show (Omniscan laser projection system)
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| 03/07/2000
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| 2000V-1058
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| Tom Casey/Laser Light
Show
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| 03/08/2000
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| 2000P-0931
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| Perkin Elmer Wallac
Inc./Wallac's Neonatal Biotinidase Kit, Models NB-1000, NB-4000
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| 03/09/2000
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| 2000V-1035
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| Donald Pascual/Laser
Light Show Mobolazer ML10-200,ML10-300,ML10-3000W
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| 03/10/2000
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| 2000V-1059
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| Rick's Durty Harrys
Entertainment Comple/Laser light show
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| 03/13/2000
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| 2000P-1077
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| The Humane Society
of the United States/Amend Current Reg Banning Sale of Small
Turtles
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| 03/13/2000
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| 2000P-1084
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| Public Citizen's Health
Group/Diabetes Drugs Troglitazone,rosiglitazone,pioglitazone
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| 03/13/2000
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| 2000P-1117
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| Med Mira Laboratories
Inc./Reclassify QuickAir Choke Reliever, Model 59-001A
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| 03/13/2000
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| 2000V-1076
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| GDM Event Services/Laser
Light Show Mobolazer ML10-200,ML10-300,ML10-300W,ML100
| Approved 06/01/2006 |
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| 03/13/2000
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| 2000P-1085
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| American Orthotic
& Prosthetic Ass/Classify cranial helment in class I,exempt
from premarket
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| 03/14/2000
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| 2000P-1120
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| UroSurge/UroSurge
Percutaneous SANS Device
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| 03/14/2000
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| 2000V-1118
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| Millenium Dance Club/Laser
Light Show(Mobolazer ML10-200,ML10-300,ML10-300W,)
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| 03/15/2000
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| 2000V-1125
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| New Pacific Inc./Laser
Light Show (Mobolazer ML10-200,ML10-300,ML10-300W,
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| 03/15/2000
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| 2000V-1126
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| SSI Production Services,
Inc./Laser Light Show(Mobolazer ML10-200,ML10-300,ML10-300W,
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| 03/15/2000
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| 2000V-1127
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| South Florida Science
Museum/Laser Light Show
| Approved 11/03/2006
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| 03/16/2000
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| 2000P-1199
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| Biovail Corporation/Approval
of ANDAs for Extended-Release
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| 03/16/2000
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| 2000V-1158
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| System Concepts/Laser
Light Show(Mobolazer ML10-200,ML10-300,ML10-300W,
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| 03/17/2000
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| 1978N-0036L
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| C.B. Fleet Company,
Inc./OTC Laxative
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| 03/22/2000
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| 2000P-1210
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| Occupational Knowledge
International/Restrict Sale of Coal Tar-Containing Products
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| 03/22/2000
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| 2000P-1211
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| Center for Food Safety/Establish
Mandatory Pre-Market Safety Testing for GE Foods
| Denied 08/25/2006 |
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| 03/23/2000
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| 2000V-1222
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| The Amphitheater/Laser
light show
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| 03/23/2000
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| 2000P-1213
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| Ferring Pharmaceuticals/ANDA
injectable formulation calcitonin salmon (caltine)
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| 03/24/2000
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| 1988N-0258
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| U.S. Small Business
Administration/Prescription Drug Marketing Act of 1987; Guideline
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| 03/24/2000
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| 1992N-0297
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| U.S. Small Business
Administration/Prescription Drug Marketing Act of 1987, Drug
Amds of 1992
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| 03/29/2000
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| 2000V-1221
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| Long Island Laser
Work/Laser Light Show (Long Island Laser Work)
| Approved 05/06/2005
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| 03/31/2000
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| 2000P-1209
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| KaVo America Corporation/Laser
Flurescence Caries Detection Device
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| Date
Filed
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| Docket
#
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| Name
of Petitioner/Subject Matter
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| Disposition
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| 03/31/2000
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| 2000P-1225
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| Equi Aid Products,
Inc./ANADA Suitability for Ivermectin Liquid for Horses
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| 03/31/2000
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| 1988N-0258
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| Pharmaceutical Distributors
Association/Prescription Drug Marketing Act of 1987; Guideline
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| 03/31/2000
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| 1992N-0297
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| Pharmaceutical Distributors
Association/Prescription Drug Marketing Act of 1987, Drug Amds
of 1992
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| 04/03/2000
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| 2000P-1227
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| Center for Science
in the Public Interes/Amend Statements Made for Dietary Supplements
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| 04/06/2000
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| 1975N-0183H
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| HFD-001 to Intnat'l
Lab Technology Corp/Health-Care Antiseptic Drug Products for
OTC Human Use
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| 04/07/2000
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| 2000P-1240
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| CPR Medical Products
Inc/Variance from Perf Std for Electrode Lead Wires & Patient
Ca
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| 04/07/2000
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| 2000P-1243
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| Pharmaceutical Associates
Inc./ANDA Suitability for Hydrocodone Bitartrate/Acetaminophen
| Withdrawn 04/26/2000
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| 04/07/2000
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| 2000V-1232
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| Ballinger Music/Laser
Light Show
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| 04/07/2000
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| 2000V-1241
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| Maryland Science Center/Laser
Light Show
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| 04/07/2000
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| 2000V-1244
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| Light Source/Laser
Light Show
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| 04/11/2000
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| 2000P-1245
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| Lachman Consultant
Services, inc./ANDA for Nizatidine Capsules, 75mg
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| 04/11/2000
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| 2000V-1247
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| Lazer Wizardry/Laser
Light Show
| Approved 10/02/2003;
Approved 10/02/2003;Terminated 06/01/2005; Approved 07/20/2005;
Approved 12/15/2006; Approved 06/05/2007 | |
| 04/13/2000
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| 2000P-1258
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| GE Marquette Medical
Systems Inc et al/Standard for Electrode Lead Wires and Patient
Cables
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| 04/14/2000
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| 2000V-1259
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| See Factory/Laser
Light Show
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| 04/14/2000
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| 2000V-1260
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| American Music Co./Laser
light show
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| 04/18/2000
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| 2000V-1261
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| FluoroScan Imaging
Systems, Inc./FluoroScan Premier mini C-Arm
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| 04/18/2000
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| 1992N-0412
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| Raj Matkari/Debarment
of Raj Matkari; Notice of Opportunity for Hearing
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| 04/19/2000
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| 2000P-1263
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| Genelabs Technologies,
Inc/Initiation of Procedure to Determine Whether DHEA is exclude
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| 04/20/2000
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| 2000V-1264
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| GE Medical Systems
OEC/Source-skin distance requirement of the performance standard
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| 04/21/2000
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| 2000P-1265
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| Biosense Webster Inc/Performance
standard for electrode lead wires & patient cabl
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| 04/25/2000
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| 2000P-1270
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| King & Spalding/ANDA
for combination oxycodone hydrochloride/acetaminophen
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| 04/26/2000
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| 2000V-1272
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| Aggessive Sound Inc./Laser
Light Show
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| 04/26/2000
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| 1983P-0187
|
| Associated
Pharmacologists & Toxicologis/Refrain from Approval of Polyurethane Contraceptive Sponge
| Denied 04/22/2005
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| 04/27/2000
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| 2000N-0598
|
| Grocery
Manufacturers of America (GMA)/Dietary Supplement Health Claim/Implementation
of Pearson De
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| 04/27/2000
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| 2000P-1271
|
| King & Spalding/Oxycodone
hydrochloirde/acetaminophen tablet 2.5mg/400mg;5.0
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| 04/27/2000
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| 2000V-1273
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| Broadway Magic/Laser
Light Show
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|
| 05/02/2000
|
| 2000P-1279
|
| Chattanooga Group
Inc/Extend the Compliance Dates for Electrode Lead Wires and
Pat
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| 05/02/2000
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| 2000P-1280
|
| Abbott Laboratories/Exempt
Devices Classified as Total Triiodothyronine Test Sys
|
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|
| 05/02/2000
|
| 2000V-1281
|
| La Curacao/Laser Light
Show, LM 8 Projection System
|
| APPROVED
09/16/2003 Approved 9/16/2003;Terminated 8/17/2005
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| 05/03/2000
|
| 2000V-1285
|
| Mid South Laser Shows/Laser
light show
|
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|
| 05/04/2000
|
| 2000A-1288
|
| Daniel Kearns/Bioburden,
Environmental Monitoring
|
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|
| 05/05/2000
|
| 2000P-1282
|
| UrosMetrics/EROS-Clitoral
Therapy Device
|
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|
| 05/05/2000
|
| 2000P-1284
|
| Grocery Mfrs of America
et al/General info for making claims ref about lack of use of
food
|
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|
| 05/05/2000
|
| 2000P-1286
|
| EP MedSystems, Inc./Performance
standard for electrode lead wires & patient cabl
|
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|
| 05/08/2000
|
| 2000V-1287
|
| Main Light Industries,
Inc/Laser Light Show
| APPROVED 05/14/2004 |
|
| 05/08/2000
|
| 1999P-4613
|
| Robert Cohen/Revoke
the Regulation That Approved Posilac
|
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|
| 05/09/2000
|
| 2000P-1289
|
| GensiaSicor Pharmaceuticals/Submission
of supplement to abbreviated new drug application
|
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|
| 05/09/2000
|
| 2000P-1290
|
| Prizm Medical, Inc./Performance
standard for electrode lead wire & patient cable
|
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|
| 05/09/2000
|
| 2000P-1291
|
| Pharmaceutical Assoc
Inc/Opioid anagesic elixir drug product suitable under an ANDA
|
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|
| 05/10/2000
|
| 2000P-1292
|
| Amrex-Zetron Inc/Performance
Standard for Electrode Lead Wires & Patient Cabl
|
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|
| 05/11/2000
|
| 2000P-1275
|
| Lipton/Health Claim:
Vegetable oil sterol esters & coronary heart d
|
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|
| 05/11/2000
|
| 1998N-0044
|
| Consumer Healthcare
Products Assn/Effect of dietary supplement on structure/function
of body
|
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|
| 05/12/2000
|
| 2000P-1295
|
| Accelerated Care Plus/Performance
Standard for Electrode Lead Wires & Patient Cabl
|
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|
| 05/12/2000
|
| 2000V-1293
|
| Vision Digital Media/Laser
light show
|
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|
| 05/12/2000
|
| 2000V-1294
|
| J.A. Investments,
Inc dba Lava Lanes of/Laser Light Show
|
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|
| 05/17/2000
|
| 2000P-1297
|
| Arnall Golden &
Gregory, LLP/Permit an OTC drug mfg to include "may contain"
in label
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| Date
Filed
|
| Docket
#
|
| Name
of Petitioner/Subject Matter
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| Disposition
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| 05/18/2000
|
| 2000V-1301
|
| G World Productions/Laser
Light Show
|
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|
| 05/18/2000
|
| 2000V-1302
|
| Carnegie Science Center/Laser
Light Show
|
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|
| 05/19/2000
|
| 2000P-1304
|
| Boston Scientific
EP Technologies/Variance from application of the performance
standard
|
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|
| 05/22/2000
|
| 2000P-1308
|
| Lachman Consultant
Services, Inc./Methimazole tablets USP,15mg/20mg are suitable
for ANDA
|
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|
| 05/22/2000
|
| 2000V-1310
|
| Pegasus Productions/Laser
Light Show Projector
|
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|
| 05/24/2000
|
| 2000P-1276
|
| McNeil Consumer Healthcare/Health
Claim: Plant stanol esters and heart disease
|
|
|
| 05/24/2000
|
| 2000V-1312
|
| Cox Chiropractic Associates,
Inc./Variance to Performance Standard for Electrical Lead Wires
|
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|
| 05/25/2000
|
| 2000P-1297
|
| Arnall Golden &
Gregory, LLP/Permit an OTC drug mfg to include "may contain"
in label
|
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|
| 05/30/2000
|
| 2000P-1322
|
| State of New York,MD,MI,WY,OH,TN,CT,VT,M/Food
Labeling and Allergen Contamination Control
|
|
|
| 05/30/2000
|
| 2000P-1324
|
| Mikart, Inc/Propoxyphene
Napsylate/Acetaminophen 100 Mg/500mg
|
|
|
| 05/30/2000
|
| 2000P-1330
|
| University of Pennsylvania/Regulation
approving the dosage approved for drug Propecia
|
|
|
| 05/30/2000
|
| 2000V-1323
|
| Allen Memorial Planetarium/Laser
Light Show
|
|
|
| 05/31/2000
|
| 2000P-1319
|
| IOMED, Inc./Performance
Standard for Electrode Lead Wires & Patient Cabl
|
|
|
| 05/31/2000
|
| 2000P-1320
|
| Allegiance Healthcare
Corporation/Performance Standard for Electrode Lead Wires &
Patient Cabl
|
|
|
| 05/31/2000
|
| 2000P-1325
|
| Aspirin Foundation
of America Inc/Declare Tylenol Arthritis Extended Relief Misbranded
|
|
|
| 06/01/2000
|
| 2000N-0598
|
| Durk Pearson and Sandy
Shaw et al./Dietary Supplement Health Claim/Implementation of
Pearson De
|
|
|
| 06/01/2000
|
| 2000P-1326
|
| American Seafood Distritutors
Assoc/Crabmeat; Amendment of Common or Usual Name Regulation
|
|
|
| 06/01/2000
|
| 2000P-1342
|
| Phoenix Scientific,
Inc./Minor change in a generic Pyrantel Pamoate Paste
|
|
|
| 06/01/2000
|
| 2000V-1327
|
| Adlaser Pty Ltd/Medi-laze
Smart Laser Product
|
|
|
| 06/05/2000
|
| 2000P-1329
|
| Arnall Golden &
Gregory, LLP./Permit dietary supplement manufacturer to include
the phrase
|
|
|
| 06/06/2000
|
| 2000V-1331
|
| Silver Hammer of Nevada
LLC./Laser Light Show
|
|
|
| 06/07/2000
|
| 2000V-1337
|
| Miner Mike's Inc./Laser
Light Show
|
|
|
| 06/08/2000
|
| 2000V-1333
|
| Falls Park Sound and
Light Show Inc./Laser Pro Projector
|
|
|
| 06/08/2000
|
| 2000V-1334
|
| J.A. Investments,
Inc./Laser Light Show
|
|
|
| 06/12/2000
|
| 2000V-1338
|
| Instant Request Inc/Laser
Light Show
|
|
|
| 06/13/2000
|
| 2000P-0586
|
| NCI, NAPA & GMA/Amend
Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz
|
|
|
| 06/13/2000
|
| 2000P-1340
|
| Able Laboratories,
Inc./Withdrawn of ROWASA Suppositories
|
|
|
| 06/13/2000
|
| 2000V-1339
|
| Club Fusion/Laser
Display Device
|
|
|
| 06/15/2000
|
| 2000P-1343
|
| E-Z-EM, Inc./Reclassify
Barium Enema Retention Catheter to Class II
|
|
|
| 06/19/2000
|
| 2000P-1349
|
| St. Jude Medical/Variance
for Electrode Lead Wires and Patient Cables
|
|
|
| 06/19/2000
|
| 2000V-1356
|
| Rock Capital Systems,
Corp./Laser light show
|
|
|
| 06/20/2000
|
| 2000P-1352
|
| GensiaSicor Pharmaceuticals/ANDA
Suitability Petition Camiodarone Hydrochloride Injectio
|
|
|
| 06/20/2000
|
| 2000V-1362
|
| Powerhouse Pro/Laser
light show
|
|
|
| 06/21/2000
|
| 2000P-1355
|
| Consumer Healthcare
Products Assoc/Labeling requirements for dietary supplements/St.John's
wort
|
|
|
| 06/22/2000
|
| 2000P-1363
|
| Iceberg Industries
Corporation (Canada)/To Amend 21 CFR 165.110 to include a Standard
of Identity
|
|
|
| 06/22/2000
|
| 2000V-1358
|
| L'ecole de Ballet
Arts Studio/Laser light show
|
|
|
| 06/23/2000
|
| 2000P-1365
|
| Lachman Consultants
Services Inc/ANDA be submitted for Fluoxetine Tablets/40 mg
|
|
|
| 06/23/2000
|
| 2000P-1419
|
| Lachman Consultant
Services Inc/ANDA for Gabapentin Tablets 100 mg 300 mg and 400
mg
|
|
|
| 06/27/2000
|
| 2000P-1369
|
| CSPI/Prohibit Making
an Unapproved Health Claim
|
|
|
| 06/27/2000
|
| 2000P-1370
|
| Medeva Pharmaceuticals,
Inc/ANDA for generic verions of Zaroxolyn Tablets(metolazone
|
| DENIED 07/30/2003
Withdrawn 7/30/2003
|
|
|
| 06/27/2000
|
| 2000P-1370
|
| Medeva Pharmaceutical,Inc./ANDA
for generic verions of Zaroxolyn Tablets(metolazone
|
| DENIED 07/30/2003
Withdrawn 7/30/2003
|
|
|
| 06/27/2000
|
| 2000P-1371
|
| IOMED,Inc/Performance
Standard for Electrode Lead Wires and Patient
|
|
|
| 06/28/2000
|
| 2000P-1372
|
| Allegiance Healthcare
Corporation/Performance Standard for Electrode Lead Wires &
Patient Cabl
|
|
|
| 06/28/2000
|
| 2000P-1375
|
| Lachman Consultant
Services, inc./ANDA for Methimazole Tablets USP,20mg
|
|
|
| 06/28/2000
|
| 2000V-1376
|
| Mars 2112/Laser Light
Show LM-10 Projection systems/spectra physics
|
|
|
| 06/28/2000
|
| 2000V-1377
|
| Mighty Ducks Hocky
Club, Inc./Laser Light Show(2) LM-10 Micro Yag Projection systems
| Approved 03/20/2006 |
|
| 06/28/2000
|
| 2000V-1381
|
| Daddy Rocks Inc/Laser
Light Show
|
|
|
| 06/29/2000
|
| 2000P-0787
|
| Abbott Laboratories/Electrode
Lead Wires/Patient Cables of 21 CFR part 898
|
|
|
| 06/30/2000
|
| 2000P-1378
|
| CTFA/Cosmetic Products
Containing Alpha Hydroxy Acids
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Date
Filed
|
| Docket
#
|
| Name
of Petitioner/Subject Matter
|
| Disposition
|
|
|
|
|
| 07/03/2000
|
| 2000V-1382
|
| Electronic Services
Agency/AIG Limelight 200 & 45 Class IIIB Laser Diode Infrared
Illum
|
|
|
| 07/06/2000
|
| 2000P-1397
|
| The Weinberg Group
Inc/Cefaclor Chewable Tablets 500mg ANDA Suitability
|
|
|
| 07/13/2000
|
| 2000V-1398
|
| Micro Dot L.L.C./Laser
light show
|
|
|
| 07/14/2000
|
| 2000P-1406
|
| Compressed
Gas Assn/Nat Welding Supply/Stay Presenting, publishing promulgating
"Fresh Air" Speeche
| Approved 05/14/2004 |
|
|
|
|
| 07/14/2000
|
| 2000V-1405
|
| Bon Secours South
Country Heart Center/Telemetry transmitter cable
|
|
|
| 07/17/2000
|
| 2000P-1243
|
| Pharmaceutical Assoc
Inc (PAI)/ANDA Suitability for Hydrocodone Bitartrate/Acetaminophen
| Denied 05/07/2001
|
|
| 07/18/2000
|
| 2000P-1411
|
| CSPI/Set a regulatory
limit for methylmercury in seafood
|
|
|
| 07/18/2000
|
| 2000V-1410
|
| B. E. Meyers &
Co., Inc./Class IIIb requirements for the IZLID Series laser
Products
|
|
|
| 07/18/2000
|
| 2000V-1417
|
| Biolase Technology,
Inc./Twilite Dental Diode Laser
|
|
|
| 07/19/2000
|
| 2000V-1421
|
| Club M.K./Laser Light
Show
|
|
|
| 07/20/2000
|
| 2000V-1420
|
| Deceptikon Visuals/Laser
Light Show
|
|
|
| 07/20/2000
|
| 2000P-1422
|
| Yamanouchi Pharma
Tecnologies Inc./Suitability Petition (OTC),Famotidine Orally
Disintegrating
|
|
|
| 07/21/2000
|
| 2000V-1423
|
| Super Bowl/Laser Light
Show
|
|
|
| 07/26/2000
|
| 2000V-1429
|
| Laser Wizardry/Laser
Light Show
|
|
|
| 07/26/2000
|
| 2000V-1430
|
| Surround Design Accociates/Laser
Light Show
|
|
|
| 08/01/2000
|
| 2000P-1431
|
| Pharmaceuitcal Associates,
Inc./ANDA for elixir containing 10mg hydrocodone bitartrate/650mg
|
|
|
| 08/02/2000
|
| 2000P-1432
|
| Paul Dowhal/Pregnancy
Warning Language on OTC Nicotine Products
|
|
|
| 08/03/2000
|
| 2000P-1433
|
| Yamanouchi Pharma
Technologies, Inc./ANDA for OTC drug product Famotidine orally
disintegrating t
|
|
|
| 08/04/2000
|
| 2000V-1438
|
| Randy Johnson &
Assoc/Laser Light Show
|
|
|
| 08/10/2000
|
| 2000P-1443
|
| Zenith Goldline Pharmaceuticals/Stay
against approval of Alendronate Sodium Tablets
|
| ANSWER
07/31/2003 answers PSA1 found in the docket
|
|
|
|
|
|
| 08/10/2000
|
| 2000V-1442
|
| Yamagata Studio/Laser
Light Show
|
|
|
| 08/11/2000
|
| 2000P-1445
|
| Zenith Goldline Pharmaceuticals/Paragraph
IV ANDAs/180-Day Exclusivity Purporses
|
| ANSWER 07/31/2003
|
|
|
| 08/11/2000
|
| 2000P-1446
|
| Teva Pharmaceuticals
USA/Mylan Nifedipine extented-release tablets 30mg
|
|
|
| 08/11/2000
|
| 2000V-1450
|
| Celebration Park/Laser
Light Show
|
|
|
| 08/14/2000
|
| 2000P-1452
|
| Cook Imaging Corporation/Supplement
to Iopamidol Injection
|
|
|
| 08/14/2000
|
| 2000V-1453
|
| Disneyland Resort/Laser
Light Show (Golden Dreams Laser Special Effects)
| Approved 06/08/2005; Termination date 12/21/2008
|
|
| 08/14/2000
|
| 2000V-1454
|
| E-3/Laser Light Show,
Mobolazer ML10-200,ML10-300,ML10-300W,
|
|
|
| 08/16/2000
|
| 2000V-1459
|
| Burning Man/Laser
Light Show
|
|
|
| 08/17/2000
|
| 2000P-1462
|
| Lachman Consultant
Services Inc./Extend Phenytoin Sodium Capsules
|
|
|
| 08/17/2000
|
| 2000V-1461
|
| DJ Distributors/Laser
Light Show,ML10-200,ML10-300,ML10-300W,ML10-1.OG,
|
|
|
| 08/17/2000
|
| 2000V-1464
|
| Candyman Productions/Laser
Light Show
|
|
|
| 08/18/2000
|
| 2000P-1466
|
| Pfizer, Inc./Non-Approvable
Letters for Neurontin
| Withdrawn 02/08/2006 |
|
| 08/18/2000
|
| 2000V-1465
|
| Family Bowling Center/Laser
Light Show
|
|
|
| 08/18/2000
|
| 2000V-1473
|
| Steve Skrien/Laser
Light Show
|
|
|
| 08/22/2000
|
| 2000P-1265
|
| Biosense Webster Inc/Performance
standard for electrode lead wires & patient cabl
|
|
|
| 08/22/2000
|
| 2000P-1468
|
| Lachman Consultant
Services, Inc./ANDA for Sertraline Hydrochloride Capsules 25mg,
50mg & 100m
|
|
|
| 08/22/2000
|
| 2000V-1469
|
| ZooBar,Inc/Laser Light
Show
|
|
|
| 08/23/2000
|
| 2000P-1470
|
| Baxter Healthcare
Corporation/ANDA 75-880 for 6%and10% PremaSol-sulfite-free (Amino
Acid)
|
|
|
| 08/23/2000
|
| 2000P-1471
|
| GensiaSicor Pharmaceuticals/ANDA
Suitability Petition Propofol Injectable Emulsion 2%
|
|
|
| 08/23/2000
|
| 2000P-1472
|
| Braintree Lab Inc/Over-the-counter
sodium phosphate bowel preparation products
|
|
|
| 08/23/2000
|
| 2000V-1476
|
| My Generation/Laser
light show
|
|
|
| 08/23/2000
|
| 2000V-1477
|
| Audio Line, Inc./Laser
Light Show
|
|
|
| 08/23/2000
|
| 2000V-1478
|
| DJ Brat/Laser light
show
|
|
|
| 08/28/2000
|
| 2000V-1479
|
| Dimension Seven/Laser
Light Show
|
|
|
| 08/28/2000
|
| 2000V-1480
|
| Dino Quiroz/Laser
Light Show
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Date
Filed
|
| Docket
#
|
| Name
of Petitioner/Subject Matter
|
| Disposition
|
|
|
|
|
| 08/28/2000
|
| 2000V-1481
|
| Christopher Todd Aasen/Laser
Light Show
|
|
|
| 08/28/2000
|
| 1975N-0183H
|
| Woodward Laboratories,
Inc./Health-Care Antiseptic Drug Products for OTC Human Use
|
|
|
| 08/29/2000
|
| 2000P-1486
|
| Equi Aid Products,
Inc/ANADA Suitability Petition for a Generic Oral Ivermectin
|
|
|
| 08/29/2000
|
| 2000V-1490
|
| The Mens Club of Dallas/Laser
Light Show
|
|
|
| 08/30/2000
|
| 2000P-1491
|
| Kraft Foods, Inc./Amend
Definition & Standard of Identy for Parmesan Cheese
|
|
|
| 08/30/2000
|
| 2000V-1492
|
| Red Line Inc./Laser
Light Show
|
|
|
| 09/01/2000
|
| 2000P-1496
|
| Lachman Consultant
Services,Inc./Gulucophage (Metformin HCI) Tablets, 625 mg and
750mg,
|
|
|
| 09/05/2000
|
| 2000P-1500
|
| Arnall Golden &
Gregory LLP/Allow Dietary Supple Mfg to list ingredients aphabetically
|
|
|
| 09/06/2000
|
| 2000P-1499
|
| Public Citizen/Remove
alosetron (Lotronex) from the market
| Answered 02/12/2004 |
|
| 09/06/2000
|
| 2000P-1518
|
| PD Regulatory Services
Inc/ANDA Suitability for Leucovorin Calcium Injection 5mg/ML
|
|
|
| 09/06/2000
|
| 1978N-0038
|
| Ciba Specialty Chemicals
Corporation/Sunscreen Drug Products
|
|
|
| 09/08/2000
|
| 2000P-1329
|
| Consumer
Healthcare Products Assoc (CHPA/Permit dietary supplement manufacturer
to include the phrase
|
|
|
|
|
|
| 09/11/2000
|
| 2000P-1510
|
| CTS Chemical Industries,
LTD (Israel)/Establish safety of Echinacea extract as a GRAS
pharmaceutic
|
|
|
| 09/11/2000
|
| 2000V-1509
|
| Crystal Night Club/Laser
Light Show
|
|
|
| 09/12/2000
|
| 2000P-1297
|
| Consumer Healthcare
Products Assoc (CHPA/Permit an OTC drug mfg to include "may
contain" in label
|
|
|
| 09/12/2000
|
| 2000V-1512
|
| Steve White/Laser
light show
|
|
|
| 09/12/2000
|
| 2000V-1514
|
| Mainstream Music/Laser
Light Show
|
|
|
| 09/15/2000
|
| 2000P-1519
|
| Smart Drug Systems
Inc/ANADA for a generic new animal drug/Heartgard chewable tblts
|
|
|
| 09/19/2000
|
| 1999V-5521
|
| Pyro Magic Inc., DBA
Laser Pyro Shows/Laser Light Show, SpectraScan LitePipe LP2-X
Mobolazer
|
|
|
| 09/21/2000
|
| 2000P-1533
|
| Cook MED Institute,
Incorporated/PTCA Balloon Catheters (74LOX)
|
|
|
| 09/22/2000
|
| 2000P-1535
|
| Boston Scientific
Corporation/Biopsy forceps covers/non-electric biopsy as Class
I devices
|
|
|
| 09/26/2000
|
| 2000V-1559
|
| B. C. T. Entertainment/Laser
display device
|
|
|
| 09/27/2000
|
| 2000V-1544
|
| Kira LLC/Laser Light
Show
|
|
|
| 09/28/2000
|
| 2000V-1546
|
| Linden Laser Systems/Laser
Light Show
|
|
|
| 09/28/2000
|
| 2000V-1547
|
| John Coodey/John Coodey
Laser Light Show
|
|
|
| 09/29/2000
|
| 2000P-1548
|
| Lachman Consultant
Services, Inc./Neoral Soft Gelatin Capsules
|
|
|
| 09/29/2000
|
| 2000V-1552
|
| Pittsburgh Penguins
Hockey Club/Laser light show
|
|
|
| 09/29/2000
|
| 2000V-1553
|
| Metropolis Theater/Laser
light show
|
|
|
| 10/02/2000
|
| 2000P-1550
|
| Glaxo Wellcome/Approve
ANDA for Cefuroxime Axetil Products
|
|
|
| 10/02/2000
|
| 2000P-1550
|
| Glaxo Welcome Inc/Approve
ANDA for Cefuroxime Axetil Products
|
|
|
| 10/02/2000
|
| 2000P-1551
|
| Arnall Golden &
Gregory, LLP/Determine an ANDA may be submitted for a propxphene
Napsylat
|
|
|
| 10/02/2000
|
| 2000P-1551
|
| Arnall Golden &
Gregory, LLP/Determine an ANDA may be submitted for a propxphene
Napsylat
|
|
|
| 10/02/2000
|
| 2000V-1549
|
| Bulldent Inc. dba
Our Place/Laser Light Show
| Approved 10/31/2003;
Terminates 10/26/2005 |
|
| 10/03/2000
|
| 2000P-1554
|
| Baxter Healthcare
Corp/Exempt pharmacy compounding systems/Class II devices from
PM
|
|
|
| 10/04/2000
|
| 2000P-1556
|
| Hyman Phelps &
McNamara PC/Policy regarding ANDA holder confidentiality
| Approved 02/27/2004 |
|
| 10/10/2000
|
| 2000P-1560
|
| Paul E. Knapp/Health
Hazard of "Radial" Sunglasses
|
|
|
| 10/12/2000
|
| 1999P-4053
|
| Mark P. Grath, Esq./Sympathominetic
Amine Phentermine
|
|
|
| 10/13/2000
|
| 2000P-1564
|
| Alcon Research LTD./Grant
a temporary exemption for one packaging component
|
|
|
| 10/16/2000
|
| 2000P-1568
|
| Lachman Consultant
Services Inc/ANDA Suitability Petition for Ursodiol Oral Suspension
|
|
|
| 10/18/2000
|
| 2000P-1572
|
| State of Alaska/Adopt
Standard of Identity for Bottled Glacier Water,Blend
|
|
|
| 10/20/2000
|
| 2000P-1574
|
| Recip AB, c/o R &
R Registrations/ANDA Suitability Petition for Potassium Lodide
65 mg Tablets
|
|
|
| 10/20/2000
|
| 2000P-1577
|
| GE OEC Medical Systems,
Inc./Variance from source-skin distance requirement of perf.
std.
|
|
|
| 10/20/2000
|
| 2000V-1573
|
| Deja Vu of Washington
Park/Laser Display Device
|
|
|
| 10/20/2000
|
| 2000V-1581
|
| Club Europe/Laser
light show
|
|
|
| 10/23/2000
|
| 2000P-1578
|
| Michael R. Harbut,
MD,MPH/Safety of Med.Devices Mfg. with Silicone Catalyzed w/
Hexach
|
|
|
| 10/23/2000
|
| 2000V-1576
|
| Insight Technology
Incorporated/AN/PEQ-2A, Target Pointer-Illuminator/Aiming Light
| Approved 10/20/06 |
|
| 10/23/2000
|
| 1976N-0052N
|
| Public Citizen's Health
Research Group/OTC Nasal Decongestants
|
|
|
| 10/23/2000
|
| 1981N-0022
|
| Public Citizen's Health
Research Group/OTC Weight Control Drug Products for Human Use
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Date
Filed
|
| Docket
#
|
| Name
of Petitioner/Subject Matter
|
| Disposition
|
|
|
|
|
| 10/24/2000
|
| 2000P-1580
|
| Lachman Consultant
Services Inc/Listed drug withdrawn from sale; Drug product not
marketed
|
|
|
| 10/25/2000
|
| 1995N-0304
|
| American Herbal Products
Assn et al/Ephedrine Alkaloids: Reports of Adverse Events; Availability
|
|
|
| 10/30/2000
|
| 2000V-1588
|
| T & B Productions/Laser
Light Show
|
|
|
| 10/30/2000
|
| 2000V-1589
|
| Quickbeam Systems
Inc./Laser Light Show
|
|
|
| 10/30/2000
|
| 2000V-1590
|
| Sound Advice/Laser
Light Show
|
|
|
| 10/31/2000
|
| 2000P-1594
|
| Highland Vet-Pharma,
LLC/ANADA for Invermectin
|
|
|
| 11/03/2000
|
| 2000P-1600
|
| SciReg, Inc./ANADA
Suitability for Ivermectin
|
|
|
| 11/03/2000
|
| 2000P-1603
|
| American
College of Obstetricians & Gyne/Rescind Any Contraindications
For Use of Misoprostol In Preg
|
|
|
|
|
|
|
|
|
| 11/06/2000
|
| 2000P-1602
|
| New Jersey General
Assembly/Remove Unapproved Children's Fluoride Supplements from
Mkt
| Withdrawn 07/07/2006
|
|
| 11/06/2000
|
| 2000V-1605
|
| Sam's Town Hotel and
Casino/Laser Light Show
|
|
|
| 11/06/2000
|
| 2000V-1606
|
| U.S. Space and Rocket
Center/Laser Light Show
|
|
|
| 11/07/2000
|
| 2000P-1607
|
| Chemically Associated
Neurological Disor/Revoke Implantation of Silicone Gel-Filled
Breast Implants
|
|
|
| 11/08/2000
|
| 2000V-1614
|
| Midwest Stereo/Laser
Light Show
|
|
|
| 11/09/2000
|
| 2000P-1623
|
| American College of
OB-GYN (ACOG)/WDL of letter issued regarding product Misoprostol
|
|
|
| 11/09/2000
|
| 2000V-1619
|
| Backwaters, Inc./Laser
light show
|
|
|
| 11/09/2000
|
| 2000V-1622
|
| Opryland Hospitality
& Attractions/Opryl/Laser light show
|
|
|
| 11/09/2000
|
| 1998P-0623
|
| Levin Fishbein Sedran
& Berman/Revoke determination that TSRH Pedicle Spinal Screw
System
|
|
|
| 11/13/2000
|
| 2000P-1617
|
| Ventro Corporation/Exemptions
Requirements of 21 CFR E-commerce Products
|
|
|
| 11/13/2000
|
| 2000V-1624
|
| The Club at II Panino/Laser
light show
|
|
|
| 11/13/2000
|
| 1978N-0038
|
| Playtex Products,
Inc./Sunscreen Drug Products
|
|
|
| 11/15/2000
|
| 2000P-1621
|
| Lipomed, Inc./ANDA
suitability for cladribine-lipomed 10 mg/5ml
|
|
|
| 11/15/2000
|
| 2000V-1627
|
| Gear Connection/Laser
light show
|
|
|
| 11/16/2000
|
| 2000V-1626
|
| S L V/Laser Light
Show
|
|
|
| 11/20/2000
|
| 2000P-1628
|
| Anthron Bethea/Insurance
Matters Regarding Unemployment & Social Security
|
|
|
| 11/22/2000
|
| 2000A-1635
|
| Advocacy, Incorporated/Pharmacological
Studies - Disability Antidiscrimination
|
|
|
| 11/24/2000
|
| 1997N-0314
|
| Jerome Stevens Pharmaceuticals
Inc/Prescription Drug Products; Levothyroxine Sodium
|
|
|
| 11/27/2000
|
| 2000V-1656
|
| Russell C Davis Planetarium/Application
for transfer of variance for laser light show
|
|
|
| 11/29/2000
|
| 2000P-1641
|
| Pharmaceutical Associates,
Inc./ANDA Suitability for Combo Hydrocodone Bitartrate &
Acetamin
|
|
|
| 11/29/2000
|
| 2000V-1643
|
| Wicked Angel Entertainment/Laser
Light Show
|
|
|
| 11/30/2000
|
| 2000P-1645
|
| McKenna & Cuneo,
L.L.P./ANDA for Mercaptopurine 100 mg Scored Oral Tablet
|
|
|
| 11/30/2000
|
| 2000V-1644
|
| Laser Billboard Corporation,
Inc./Laser Light Show
|
|
|
| 11/30/2000
|
| 2000V-1646
|
| Eclipse/Laser Light
Show
|
|
|
| 11/30/2000
|
| 2000V-1653
|
| Marathon Marketing,
LLC/Laser light show
|
|
|
| 12/04/2000
|
| 2000P-1648
|
| NeuroControl Corporation/Electrode
Lead Wires and Patient Cables
|
|
|
| 12/04/2000
|
| 2000V-1647
|
| Lumatech Lighting/Laser
Light Show
|
|
|
| 12/05/2000
|
| 2000P-1668
|
| CSPI/Action against
mfrs&dists of garlic supplements misbranded
|
|
|
| 12/06/2000
|
| 2000P-1655
|
| HighlandVet-Pharma
LLC/ANADA Application; Proposed product differ from appoved
list
|
|
|
| 12/06/2000
|
| 2000P-1657
|
| Cintas Corp./Request
for exemption to allow phrase "may contain" on conta
|
|
|
| 12/06/2000
|
| 2000V-1654
|
| Safety & Compliance
Consulting/Laser Light Show
|
|
|
| 12/12/2000
|
| 2000V-1667
|
| TSI Incorporated/LS200
LaserSpeed Velocity Measurement System
|
|
|
| 12/14/2000
|
| 2000V-1670
|
| Pure Bar Room/Laser
Light Show
|
|
|
| 12/15/2000
|
| 2000P-1671
|
| Pharmacists Planning
Service, Inc./Patient Medicine Guides (MedGuides)/Cox-II &
NSAID
| Approved 07/26/05 |
|
| 12/18/2000
|
| 2000V-1673
|
| The DJ Store/Request
for Laser Light Show
|
|
|
| 12/19/2000
|
| 2000P-1675
|
| Biosite Diagnostics,
Incorporated/Triage B-Type Natriuetic Peptide (BNP) Test (K003475)
|
|
|
| 12/19/2000
|
| 2000P-1676
|
| Southwest Texas State
University/Electrode Lead Wires and Patient Cables
|
|
|
| 12/20/2000
|
| 2000P-1491
|
| Sartori Foods Corporation
./Amend Definition & Standard of Identy for Parmesan Cheese
|
|
|
| 12/20/2000
|
| 2000P-1687
|
| Sartori Food Corp./Amend
definition & standard of identity for parmesan cheese
|
|
|
| 12/21/2000
|
| 2000P-1680
|
| Protein Technologies
International, Inc./Amending the Method of Calculating Protein
Content
|
|
|
| 12/22/2000
|
| 2000V-1685
|
| Storm Theater Group
at Mamdalay Bay/Laser Light Show Lasermedia
|
|
Page update
June 11, 2007
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