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| | | | | |
| |
|
|
| Dockets Entered
On February 5, 2004
Table of Contents
|
|
|
|
|
|
|
| |
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1994N-0418
|
| Order for Certain Class III Devices, including S&E info
|
| |
|
|
| 1995N-0304
|
| Ephedrine Alkaloids: Reports of Adverse Events; Availability
|
| |
|
|
| 1995S-0158
|
| Community Disclosure of Institutional Review Boards
|
| |
|
|
| 1997D-0411
|
| (BSE) in Products for Human Use; Guidance for Industry.
|
| |
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
| |
|
|
| 1998P-0620
|
| Withdrawn Protocol Review Pkg for Amiodarone HCL Tablets
|
| |
|
|
| 1999V-0184
|
| Variance Laser Light Show Projector Model #LP1
|
| |
|
|
| 2000P-0685
|
| Revise of Yogurt Standards
|
| |
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
| |
|
|
| 2001P-0239
|
| ANDA Suitability for Amlodipine "Caplet"
|
| |
|
|
| 2001P-0241
|
| ANDA Suitability for Paroxetine "Caplet"
|
| |
|
|
| 2001P-0440
|
| ANDA Suitability Petition for Ganciclovir Sodium Injection
|
| |
|
|
| 2001P-0511
|
| ANDA suitability for hydrocortisone acetate lotion 2.5%
|
| |
|
|
| 2002F-0220
|
| Acesulfame Potassium as General-Purpose Sweetener
|
| |
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
| |
|
|
| 2002P-0078
|
| ANDA for Baclofen Orally Disintegrating Tablets, 10 mg & 20
|
| |
|
|
| 2002P-0226
|
| ANDA for methotrexate sodium oral solution, 5mg/ml
|
| |
|
|
| 2002P-0297
|
| ANDA for Propoxyphene Hydrochloride, Acetaminophen&Caffeine
|
| |
|
|
| 2002P-0380
|
| Abbreviated New Drug Application (ANDA) for Loperamide Hydro
|
| |
|
|
| 2002P-0386
|
| Abbreviated new drug application (ANDA)7.5 mg hydrocodone
|
| |
|
|
| 2002P-0406
|
| ANDA Suitability for Amoxicillin & Clavulanate Potassium
|
| |
|
|
| 2002P-0414
|
| Cefuroxime Axetil Tablets Oral suspension 125mg & 250mg ANDA
|
| |
|
|
| 2002P-0424
|
| ANDA for Loperamide Hydrochloride 1 mg Soft Gelatin Capsules
|
| |
|
|
| 2002P-0436
|
| ANDA for ribavirin, USP in a water soluble film-coated table
|
| |
|
|
| 2002P-0444
|
| cefpodoxime Proxetil talbets for Oral suspension 50mg/100mg
|
| |
|
|
| 2002P-0473
|
| ANDA for Naproxen Sodium, 220mg (equivalent to 200 mg Naprox
|
| |
|
|
| 2002P-0499
|
| ANDA Suitability for Metformin Hydrochloride Tablets Oral So
|
| |
|
|
| 2003D-0290
|
| Compounding of Drugs for Use in Animals Compliance Policy Guide
|
| |
|
|
| 2003E-0037
|
| Patent Term Extension Application for LUMIGAN No. 5,688,819
|
| |
|
|
| 2003E-0081
|
| Patent Term Extension for ORTHO-EVRA No. 5,876,746
|
| |
|
|
| 2003E-0147
|
| Patent Extension Application for FROVA, No. 5,464,864
|
| |
|
|
| 2003E-0245
|
| Patent Extension for Remodulin (Treprostinil sodium), 5,153,222
|
| |
|
|
| 2003E-0248
|
| Patent Extension for Extranaeal (icodextrin), 4,761,237
|
| |
|
|
| 2003N-0308
|
| CIVIL MONEY PENALTIES HEARINGS; MAXIMUM PENALTY AMOUNTS AND Compliance with the FEDERAL CIVIL PENALTIES Inflation Adjustment Act
|
| |
|
|
| 2003N-0341
|
| Requirements for Submission of In Vivo Bioequivalence Data
|
| |
|
|
| 2003N-0422
|
| Annual Stakeholder Meeting on the Implementation of MDUFMA Provisions
|
|
| | | | | | | | |
| |
|
|
| 2003P-0082
|
| Abbreviated New Drug Application (ANDA) for Ursodiol Oral
|
| |
|
|
| 2003P-0159
|
| Venlafaxine Hydrochloride Extended-Release Tablets
|
|
| |
|
| 2003P-0188
|
| ANDA Suitability for Glyburide & Metformin HCl Tablets
|
| |
|
|
| 2003P-0218
|
| ANDA for Glipizide and Metformin HCI Tablets for Oral Solution
|
| |
|
|
| 2003P-0220
|
| ANDA for Carboplatin, 10mg/mL, in strength of 600 mg/60 mL
|
| |
|
|
| 2003P-0237
|
| ANDA Suitability Petition for Propranolol HCI Extended-Release Tablets, 60 mg, 80 mg, 120 mg and 160 mg
|
| |
|
|
| 2003P-0279
|
| Abbreviated New Drug Application for a Topical solution of the three actives fluocinolone acetonide, hydroquinone, and tretinoin
|
| |
|
|
| 2003P-0284
|
| Lexapro (escitalopram oxalate) tablets 5mg (NDA 21-323, Product 001),mfged by Forest Laboratories have been voluntarily withdrawn or withheld from sale for safety or efficacy reasons
|
| |
|
|
| 2003P-0298
|
| Diclofenac Potassium Capusles 25 mg suitable for submission as ANDA
|
| |
|
|
| 2003P-0321
|
| Refrain from approving an Abbreviated New Drug Application (ANDA's) for Riavirin
|
| |
|
|
| 2003P-0357
|
| Update the Drug/Laboratory Test Interactions section of the prescribing information of all strenghts of Premarin tablets (.3mg, .45mg, .625mg, 1.25mg, 2.5mg) to recognize the decfeased levels of testo
|
|
|
|
|
|
| 2003P-0362
|
| Over-the-counter Hearing Aids
|
| |
|
|
| 2003P-0363
|
| Professional and Patient Labeling for Hearing Aid Devices
|
| |
|
|
| 2003P-0365
|
| Galderma product, solage containing 2% Mequinol, and 0.01% tretinoin, NDA 20-922 can be formulated as a topical solution with the substitution of Hydroquinone at 4% for the 2% mequinol as an ANDA
|
|
|
|
|
|
|
|
|
| 2003P-0366
|
| Amend approval for a nonprescription form of Prilosec (omeprazole magnesium)
|
| |
|
|
| 2003P-0453
|
| Abbreviated new drug applications (ANDAs) suitability for hydrocodone bitartrate
|
| |
|
|
| 2003P-0460
|
| ANDA Suitability 200 mg Carisoprodol and 325 mg of Acetaminophen combination drug product ; 200 mg Carisprodol, 325 mg Acetaminophen, and 16 mg Codeine Phosphate drug product
|
| |
|
|
| 2003P-0475
|
| Drug Product containing hydrocodone bitartrate 5 mg and acetaminophen 325 mg in liquid form oral administration is suitable for evaluation under an ANDA
|
| |
|
|
| 2003P-0479
|
| Allow importation of Canadian versions of drugs that are approved to the United States
|
| |
|
|
| 2003P-0534
|
| Glyburide and metformin hydrochloride Oral Solution 1.25 mg/250 mg per 5 mL; 2.5 mg/500 mg per 10
|
| |
|
|
| 2003V-0435
|
| Laser Light Show
|
| |
|
|
| 2004D-0002
|
| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
|
| |
|
|
| 2004D-0028
|
| Draft Consumer Advisory regarding Advice for Subgroups of a Population regarding Mercury in Fish and Shellfish
|
| |
|
|
| 2004P-0054
|
| Abbreviated New Drug Application (ANDA) for Doxycycline Hyclate Capsules, 75mg and 100 mg (NDA) 50-582
|
| |
|
|
| 2004V-0052
|
| Laser Light Show
|
| |
|
|
| 2004V-0053
|
| Laser Light Show
|
| |
|
|
| 1994N-0418
|
| Order for Certain Class III Devices, including S&E info
|
| |
|
|
| C
8
Attached CV
|
| National Center for Early Defibrillation (NCED)
|
| Vol #:
|
| 23
|
| |
|
|
| C 9
|
| B. Riegel, DNSc,RN,CS,FAAN
|
| Vol #:
|
| 23
|
| |
|
|
| C 10
|
| M. Wayne,MD,FACEP
|
| Vol #:
|
| 23
|
| |
|
|
| C 11
|
| T. Terndrup,MD
|
| Vol #:
|
| 23
|
| |
|
|
| C 12
|
| L. Becker, MD
|
| Vol #:
|
| 23
|
| |
|
|
| C 13
|
| W. Tacker, Jr.MD,PhD
|
| Vol #:
|
| 23
|
| |
|
|
| C 14
|
| J. Ornato,MD,FACP,FACC,FACEP
|
| Vol #:
|
| 23
|
|
| | | | | | | | |
| |
|
|
| 1995N-0304
|
| Ephedrine Alkaloids: Reports of Adverse Events; Availability
|
| |
|
|
| C 4050
|
| J. Shelton, RN
|
| Vol #:
|
| 374
|
| |
|
|
| C 4051
|
| J. Shelton, RN
|
| Vol #:
|
| 374
|
| |
|
|
| C
4052
|
| Nutraceutical Corporation
|
| Vol #:
|
| 374
|
| |
|
|
| 1995S-0158
|
| Community Disclosure of Institutional Review Boards
|
| |
|
|
| RPT
16
|
| Harborview Medical Center
|
| Vol #:
|
| 19
|
| |
|
|
| 1997D-0411
|
| (BSE) in Products for Human Use; Guidance for Industry.
|
| |
|
|
| LET
1
|
| Gelatin Manufacturers of Europe (GME) and the Gelatin Manufacturers Institute of America (GMIA)
|
| Vol #:
|
| 2
|
| |
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| LET
12546
|
| NBTY Inc.
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12547
|
| NBTY Inc.
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12548
|
| NBTY Inc.
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12549
|
| NBTY Inc.
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12550
|
| NBTY Inc.
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12551
|
| NBTY Inc.
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12552
|
| NBTY Inc.
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12553
|
| NBTY Inc.
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12554
|
| NBTY Inc.
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12555
|
| NBTY Inc.
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12556
|
| NBTY Inc.
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12557
|
| NBTY Inc.
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12558
|
| NBTY Inc.
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12559
|
| NBTY inc.
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12560
|
| NBTY Inc.
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12561
|
| Awareness Corporation
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12562
|
| Solstice Medicine Company
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12563
|
| Solstice Medicine Company
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12564
|
| Solstice Medicine Company
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12565
|
| Solstice Medicine Company
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12566
|
| Solstice Medicine Company
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12567
|
| Solstice Medicine Company
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12568
|
| Solstice Medicine Company
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12569
|
| Solstice Medicine Company
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12570
|
| Solstice Medicine Company
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12571
|
| Solstice Medicine Company
|
| Vol #:
|
| 102
|
|
| | | | | | | | |
| |
|
|
| LET
12572
|
| Solstice Medicine Company
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12573
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12574
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12575
|
| PhytoPharmica Natural Medicines
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12576
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12577
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12578
|
| NBTY Inc.
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12579
|
| NBTY Inc.
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12580
|
| NBTY Inc.
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12581
|
| NBTy Inc.
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12582
|
| NBTY Inc.
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12583
|
| NBTY Inc.
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12584
|
| NBTY Inc.
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12585
|
| NBTY Inc.
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12586
|
| NBTY Inc.
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12587
|
| NBTY Inc.
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12588
|
| NBTY Inc.
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12589
|
| NBTY Inc.
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12590
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12591
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12592
|
| PhytoPharmica Natural Medicines
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12593
|
| PhytoPharmica Natural Medicines
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12594
|
| PhytoPharmica Natural Medicines
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12595
|
| NBTY Inc.
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12596
|
| NBTY Inc.
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12597
|
| NBTY Inc.
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12598
|
| NBTY Inc.
|
| Vol #:
|
| 102
|
| |
|
|
| LET
12599
|
| NBTY Inc.
|
| Vol #:
|
| 102
|
| |
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
| |
|
|
| C 7373
|
| D. Fish
|
| Vol #:
|
| 307
|
| |
|
|
| C 7374
|
| O. VaVerka
|
| Vol #:
|
| 307
|
| |
|
|
| C 7375
|
| G. Bleifeld
|
| Vol #:
|
| 307
|
| |
|
|
| C 7376
|
| N. Franco
|
| Vol #:
|
| 307
|
| |
|
|
| C 7377
|
| L. Ballard
|
| Vol #:
|
| 307
|
| |
|
|
| 1998P-0620
|
| Withdrawn Protocol Review Pkg for Amiodarone HCL Tablets
|
|
| | | | | | | | |
| |
|
|
| LET
6
|
| HFD-7 to Wyeth Pharmaceuticals
|
| Vol #:
|
| 1
|
| |
|
|
| 1999V-0184
|
| Variance Laser Light Show Projector Model #LP1
|
| |
|
|
| VRA
4
|
| HFZ-300 to John's Laser Productions dba J&K Laser Productions
|
| Vol #:
|
| 1
|
| |
|
|
| 2000P-0685
|
| Revise of Yogurt Standards
|
| |
|
|
| C
16
|
| General Mills
|
| Vol #:
|
| 2
|
| |
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
| |
|
|
| C 353
|
| K. Lackner
|
| Vol #:
|
| 125
|
| |
|
|
| C 354
|
| T. MacDougall
|
| Vol #:
|
| 125
|
| |
|
|
| C 355
|
| L. Kramer
|
| Vol #:
|
| 125
|
| |
|
|
| 2001P-0239
|
| ANDA Suitability for Amlodipine "Caplet"
|
| |
|
|
| LET
1
|
| HFD-600 to Cipher Pharmaceuticals Limited
|
| Vol #:
|
| 1
|
| |
|
|
| 2001P-0241
|
| ANDA Suitability for Paroxetine "Caplet"
|
| |
|
|
| LET
1
|
| HFD-600 to Cipher Pharmaceuticals Limited
|
| Vol #:
|
| 1
|
| |
|
|
| 2001P-0440
|
| ANDA Suitability Petition for Ganciclovir Sodium Injection
|
|
|
| LET
1
|
| HFD-600 to Ben Venue Laboratories Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2001P-0511
|
| ANDA suitability for hydrocortisone acetate lotion 2.5%
|
| |
|
|
| LET
1
|
| HFD-600 to Ferndale Laboratories Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2002F-0220
|
| Acesulfame Potassium as General-Purpose Sweetener
|
| |
|
|
| C
1
|
| Calorie Control Council (the Council)
|
| Vol #:
|
| 1
|
| |
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
| |
|
|
| REF
3
|
| OMB review for Publication Date February 3, 2003
|
| Vol #:
|
| 23
|
| |
|
|
| 2002P-0078
|
| ANDA for Baclofen Orally Disintegrating Tablets, 10 mg & 20
|
| |
|
|
| LET
1
|
| HFD-600 to Kleinfeld, Kaplan and Becker
|
| Vol #:
|
| 1
|
| |
|
|
| 2002P-0226
|
| ANDA for methotrexate sodium oral solution, 5mg/ml
|
| |
|
|
| LET
1
|
| HFD-600 to Kirkpatrick & Lockhart LLP
|
| Vol #:
|
| 1
|
| |
|
|
| 2002P-0297
|
| ANDA for Propoxyphene Hydrochloride, Acetaminophen&Caffeine
|
|
|
| LET
1
|
| HFD-600 to Lachman Consultant Services
|
| Vol #:
|
| 1
|
| |
|
|
| 2002P-0380
|
| Abbreviated New Drug Application (ANDA) for Loperamide Hydro
|
| |
|
|
| LET
1
|
| HFD-600 to Banner Pharmacaps Inc
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
| |
|
|
| 2002P-0386
|
| Abbreviated new drug application (ANDA)7.5 mg hydrocodone
|
| |
|
|
| LET
1
|
| HFD-600 to Pharmaceutical Associates Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2002P-0406
|
| ANDA Suitability for Amoxicillin & Clavulanate Potassium
|
| |
|
|
| C
3
Enclosed
|
| GlaxoSmithKline (GSK)
|
| Vol #:
|
| 2
|
| |
|
|
| LET
1
|
| HFD-600 to The Weinberg Group Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2002P-0414
|
| Cefuroxime Axetil Tablets Oral suspension 125mg & 250mg ANDA
|
| |
|
|
| LET
1
|
| HFD-600 to The Weinberg Group Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2002P-0424
|
| ANDA for Loperamide Hydrochloride 1 mg Soft Gelatin Capsules
|
| |
|
|
| LET
1
|
| HFD-600 to Banner Pharmacaps Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2002P-0436
|
| ANDA for ribavirin, USP in a water soluble film-coated table
|
| |
|
|
| LET
1
|
| HFD-600 to Frommer Lawrence & Haug LLP
|
| Vol #:
|
| 1
|
| |
|
|
| 2002P-0444
|
| cefpodoxime Proxetil talbets for Oral suspension 50mg/100mg
|
| |
|
|
| LET
1
|
| HFD-600 to The Weinberg Group Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2002P-0473
|
| ANDA for Naproxen Sodium, 220mg (equivalent to 200 mg Naprox
|
| |
|
|
| LET
1
|
| HFD-600 to Banner Pharmacaps, Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2002P-0499
|
| ANDA Suitability for Metformin Hydrochloride Tablets Oral So
|
| |
|
|
| LET
1
|
| HFD-600 to The Weinberg Group Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2003D-0290
|
| Compounding of Drugs for Use in Animals Compliance Policy Guide
|
| |
|
|
| C
3
|
| D&L White
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0037
|
| Patent Term Extension Application for LUMIGAN No. 5,688,819
|
| |
|
|
| LET
3
|
| HFD-5 to U S Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0081
|
| Patent Term Extension for ORTHO-EVRA No. 5,876,746
|
| |
|
|
| LET
3
|
| HFD-5 to U S Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0147
|
| Patent Extension Application for FROVA, No. 5,464,864
|
| |
|
|
| LET
4
|
| HFD-5 to U S Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0245
|
| Patent Extension for Remodulin (Treprostinil sodium), 5,153,222
|
| |
|
|
| LET
4
|
| HFD-5 to U S Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0248
|
| Patent Extension for Extranaeal (icodextrin), 4,761,237
|
| |
|
|
| LET
3
|
| HFD-5 to U S Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
| |
|
|
| 2003N-0308
|
| CIVIL MONEY PENALTIES HEARINGS; MAXIMUM PENALTY AMOUNTS AND Compliance with the FEDERAL CIVIL PENALTIES Inflation Adjustment Act
|
| |
|
|
| M
1
|
| HFP-60
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0341
|
| Requirements for Submission of In Vivo Bioequivalence Data
|
| |
|
|
| C
4
|
| Hogan & Hartson. LLP
|
| Vol #:
|
| 1
|
| |
|
|
| C
5
|
| Eon Labs, Inc
|
| Vol #:
|
| 2
|
| |
|
|
| 2003N-0422
|
| Annual Stakeholder Meeting on the Implementation of MDUFMA Provisions
|
| |
|
|
| TR
1
|
| Transcript of the December 3, 2003 Stakeholder Meeting
|
| Vol #:
|
| 2
|
| |
|
|
| 2003P-0082
|
| Abbreviated New Drug Application (ANDA) for Ursodiol Oral
|
| |
|
|
| LET
1
|
| HFD-600 to Lachman Consultant Services Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0159
|
| Venlafaxine Hydrochloride Extended-Release Tablets
|
| |
|
|
| AMD
1
|
| Lachman Consultant Services, Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0188
|
| ANDA Suitability for Glyburide & Metformin HCl Tablets
|
| |
|
|
| AMD
1
|
| The Weinberg Group Inc
|
| Vol #:
|
| 1
|
| |
|
|
| LET
1
|
| HFD-600 to The Weinberg Group Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0218
|
| ANDA for Glipizide and Metformin HCI Tablets for Oral Solution
|
| |
|
|
| AMD
1
|
| The Weinberg Group Inc
|
| Vol #:
|
| 1
|
| |
|
|
| LET
1
|
| HFD-600 to The Weinberg Group Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0220
|
| ANDA for Carboplatin, 10mg/mL, in strength of 600 mg/60 mL
|
| |
|
|
| LET
1
|
| HFD-600 to Faulding Pharmaceutical Company
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0237
|
| ANDA Suitability Petition for Propranolol HCI Extended-Release Tablets, 60 mg, 80 mg, 120 mg and 160 mg
|
| |
|
|
| LET
1
|
| HFD-600 to URL Mutual
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0279
|
| Abbreviated New Drug Application for a Topical solution of the three actives fluocinolone acetonide, hydroquinone, and tretinoin
|
| |
|
|
| LET
1
|
| HFD-600 to Jerussi Consulting, Inc
|
| Vol #:
|
| 1
|
| |
|
|
| RC
1
|
| Jerussi Consulting, Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0284
|
| Lexapro (escitalopram oxalate) tablets 5mg (NDA 21-323, Product 001),mfged by Forest Laboratories have been voluntarily withdrawn or withheld from sale for safety or efficacy reasons
|
| |
|
|
| LET
2
|
| HFD-7 to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0298
|
| Diclofenac Potassium Capusles 25 mg suitable for submission as ANDA
|
| |
|
|
| LET
1
|
| HFD-600 to The Weinberg Group Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0321
|
| Refrain from approving an Abbreviated New Drug Application (ANDA's) for Riavirin
|
| |
|
|
| LET
2
|
| HFD-5 to Hogan & Hartson
|
| Vol #:
|
| 2
|
|
| | | | | | | | |
| |
|
|
| 2003P-0357
|
| Update the Drug/Laboratory Test Interactions section of the prescribing information of all strenghts of Premarin tablets (.3mg, .45mg, .625mg, 1.25mg, 2.5mg) to recognize the decfeased levels of testo
|
|
|
|
|
|
|
|
|
| LET
1
|
| HFD-5 to Beth Rosenshein
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0362
|
| Over-the-counter Hearing Aids
|
| |
|
|
| C
12
|
| Lancaster Audiology Services
|
| Vol #:
|
| 1
|
| |
|
|
| C
13
Index,
Appendix A,
B, C
|
| Academy of Dispensing Audiologists (ADA)
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0363
|
| Professional and Patient Labeling for Hearing Aid Devices
|
| |
|
|
| C
3
Appendix
A, B, C
|
| Academy of Dispensing Audiologists (ADA)
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0365
|
| Galderma product, solage containing 2% Mequinol, and 0.01% tretinoin, NDA 20-922 can be formulated as a topical solution with the substitution of Hydroquinone at 4% for the 2% mequinol as an ANDA
|
|
|
|
|
|
|
| |
|
|
| C
2
|
| Jerussi Consulting, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| LET
1
|
| HFD-600 to Jerussi Consulting Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0366
|
| Amend approval for a nonprescription form of Prilosec (omeprazole magnesium)
|
| |
|
|
| LET
2
|
| HFD-5 to Mattingly, Stanger & Malur
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0453
|
| Abbreviated new drug applications (ANDAs) suitability for hydrocodone bitartrate
|
| |
|
|
| LET
1
|
| HFD-600 to King & Spalding LLP
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0460
|
| ANDA Suitability 200 mg Carisoprodol and 325 mg of Acetaminophen combination drug product ; 200 mg Carisprodol, 325 mg Acetaminophen, and 16 mg Codeine Phosphate drug product
|
|
|
|
|
|
|
|
|
| LET
1
|
| HFD-600 to Anabolic Laboratories, Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0475
|
| Drug Product containing hydrocodone bitartrate 5 mg and acetaminophen 325 mg in liquid form oral administration is suitable for evaluation under an ANDA
|
| |
|
|
| LET
1
|
| HFD-600 to International Regulatory Business Consultants LLC
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0479
|
| Allow importation of Canadian versions of drugs that are approved to the United States
|
| |
|
|
| EMC 36
|
| B Richardson
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 37
|
| Herman
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0534
|
| Glyburide and metformin hydrochloride Oral Solution 1.25 mg/250 mg per 5 mL; 2.5 mg/500 mg per 10
|
| |
|
|
| AMD
1
|
| Lachman Consultant Services, Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2003V-0435
|
| Laser Light Show
|
| |
|
|
| VRA
1
|
| HFZ-300 to Warner Bros. Entertainment Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2004D-0002
|
| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
|
|
|
| C
1
|
| University of Florida
|
| Vol #:
|
| 1
|
| |
|
|
| EC 1
|
| Galing, Cindy
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
| |
|
|
| EMC 5
|
| C Bromm
|
| Vol #:
|
| 1
|
| |
|
|
| 2004D-0028
|
| Draft Consumer Advisory regarding Advice for Subgroups of a Population regarding Mercury in Fish and Shellfish
|
| |
|
|
| EMC 1
|
| J Cosky
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0054
|
| Abbreviated New Drug Application (ANDA) for Doxycycline Hyclate Capsules, 75mg and 100 mg (NDA) 50-582
|
| |
|
|
| ACK 1
|
| HFA-305 to Mutual Pharmaceutical Company, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
|
| Mutual Pharmaceutical Company, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004V-0052
|
| Laser Light Show
|
| |
|
|
| ACK 1
|
| HFA-305 to Clark Planetarium
|
| Vol #:
|
| 1
|
| |
|
|
| VAR
1
|
| Clark Planetarium
|
| Vol #:
|
| 1
|
| |
|
|
| 2004V-0053
|
| Laser Light Show
|
| |
|
|
| ACK 1
|
| HFA-305 to Minolta Planetarium /De Anza C. College
|
| Vol #:
|
| 1
|
| |
|
|
| VAR
1
|
| Minolta Planetarium /De Anza C. College
|
| Vol #:
|
| 1
|
|
|
|
|
