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| Dockets Entered
On September 30, 2004
Table of Contents
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| Docket #
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| Title
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| 1977P-0185
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| Ban on Cigarettes Containing Nicotine
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2001N-0234
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| Food Contact Substance Notification System
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| 2002V-0143
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| Laser Light Show
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| 2003E-0033
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| Patent Extension Application for DERMAGRAFT No. 4,963,489
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| 2003E-0260
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| Patent Extension for Amevive (alefacept), 5,547,853
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| 2003N-0161
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| Medical Devices;Reprocessed Single-Use Devices;Termination
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| 2003N-0565
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Generic FDA Rapid Response Surveys
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| 2003P-0126
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| Refrain from approving (ANDA)for Levothyroxine Sodium Tablet
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| 2003P-0270
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| Prohibit False and Misleading Labeling
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| 2003P-0357
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| 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
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| 2003P-0387
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| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
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| 2003P-0564
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| 513(f) Reclassification Petition for In Vitro Diagnostics for Anti-Hepatitis A Virus IgM and Total Antibodies
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| 2004D-0385
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| Class II Special Controls Guidance Document: Hepatitis A Serological Assays for the Clinical Laboratory Diagnosis of Hepatitis A Virus
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| 2004M-0145
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| P020006 - Enteryx Procedure Kit, Approved 4/22/03
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| 2004M-0147
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| P890064/S009 - Digene Hybrid Capture 2 (HC2) High-Risk HPV DNA Test
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| 2004M-0165
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| H020008; OP-1 Putty
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| 2004M-0199
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| P030032 - Hylaform (hylan B gel)
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| 2004M-0200
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| P010014 - Oxford Meniscal Unicompartmental Knee System
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| 2004M-0207
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| P970027 - Abbott AxSYM Anti-HCV
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| 2004M-0248
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| P030023 - Oculaid Capsular Tension Ring (Model 275 10/12 mm and Model 276 11/13 mm)
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| 2004M-0249
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| P000054 - INFUSE Bone Graft
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| 2004M-0250
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| P030035 - St. Jude Frontier Biventricular Cardiac Pacing System including the Frontier Model 5508 and 5508L Pulse Generators, the Aescula LV Model 1055K Lead and the Model 3307 v4.4.2m programmer so
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| 2004M-0253
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| P980007 - AxSYM Free PSA
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| 2004M-0256
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| Advanced Bionics; Premarket Approval for Precision Spinal Cord Stimulation (SCS) System; P030017.
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| 2004M-0259
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| P030045 -IntraStent DoubleStrut Stent
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| 2004M-0260
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| P010062 - Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear
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| 2004N-0017
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Pilot Program for Medical Devices
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| 2004N-0242
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| Institutional Review Boards; Registration Requirements
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| 2004N-0264
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| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
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| 2004N-0355
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| Scientific Considerations Related to Developing Follow-on Protein Products
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| 2004P-0139
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| approval of generic versions of Concerta (methylphenidate HCI extended-release tablets are both bioequivalent and clinically equivalent to the innovator product
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| 2004P-0162
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| Zoloft (sertaline hydrochloride) Tablets 150 mg and 200 mg
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| 2004P-0202
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| Notify State & Federal regulators of GRAS requirements of milk protein Concentrate
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| 2004P-0386
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| Reject New Drug Application 21-695
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| | | | | | | | |
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| 2004S-0233
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| Stimulating Innovation in Medical Technologies
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| 1977P-0185
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| Ban on Cigarettes Containing Nicotine
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| ACK 2
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| HFA-305 to Director and General Counsel
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| Vol #:
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| 1
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
14552
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| NBTY, Inc.
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| Vol #:
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| 127
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| LET
14553
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| NBTY, Inc.
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| Vol #:
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| 127
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| LET
14554
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| Enzymatic Therapy
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| Vol #:
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| 127
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| LET
14555
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| Enzymatic Therapy
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| Vol #:
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| 127
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| LET
14556
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| Enzymatic Therapy
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| Vol #:
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| 127
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| LET
14557
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| Enzymatic Therapy
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| Vol #:
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| 127
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| LET
14558
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| Enzymatic Therapy
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| Vol #:
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| 127
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| LET
14559
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| Enzymatic Therapy
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| Vol #:
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| 127
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| LET
14560
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| Natural Factors Nutritional Products Inc.
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| Vol #:
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| 127
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| LET
14561
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| Perrigo Company of South Carolina
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| Vol #:
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| 127
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| LET
14562
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| Perrigo Company of South Carolina
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| Vol #:
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| 127
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| LET
14563
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| Perrigo Company of South Carolina
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| Vol #:
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| 127
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| LET
14564
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| Perrigo Company of South Carolina
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| Vol #:
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| 127
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| LET
14565
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| Perrigo Company of South Carolina
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| Vol #:
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| 127
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| LET
14566
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| Perrigo Company of South Carolina
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| Vol #:
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| 127
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| LET
14567
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| Perrigo Company of South Carolina
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| Vol #:
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| 127
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| LET
14568
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| Perrigo Company of South Carolina
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| Vol #:
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| 127
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| LET
14569
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| Nature's Sunshine Products, Inc.
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| Vol #:
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| 127
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| LET
14570
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| Ortho Molecular Products
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| Vol #:
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| 127
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| LET
14571
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 127
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| LET
14572
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 127
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| LET
14573
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 127
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| LET
14574
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 127
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| LET
14575
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 127
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| LET
14576
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 127
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| LET
14577
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| Pharmessen Scientific
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| Vol #:
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| 127
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| LET
14578
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| Pharmessen Scientific
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| Vol #:
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| 127
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| LET
14579
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| Pharmessen Scientific
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| Vol #:
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| 127
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| LET
14580
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| Pharmessen Scientific
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| Vol #:
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| 127
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| LET
14581
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| Pharmessen Scientific
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| Vol #:
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| 127
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| | | | | | | | |
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| 2001N-0234
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| Food Contact Substance Notification System
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|
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| NWL
1
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| FDA
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| Vol #:
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| 1
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|
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| 2002V-0143
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| Laser Light Show
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|
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| EXP
1
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| Pacific Laser Productions
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| Vol #:
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| 1
|
|
|
| 2003E-0033
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| Patent Extension Application for DERMAGRAFT No. 4,963,489
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|
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| N
1
|
| FDA
|
| Vol #:
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| 1
|
|
|
| 2003E-0260
|
| Patent Extension for Amevive (alefacept), 5,547,853
|
|
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| N
1
|
| FDA
|
| Vol #:
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| 1
|
|
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| 2003N-0161
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| Medical Devices;Reprocessed Single-Use Devices;Termination
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|
|
| C
4
Attachment 1,
2
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| Guidant Corporation (Guidant or the Company)
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| Vol #:
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| 1
|
|
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| 2003N-0565
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Generic FDA Rapid Response Surveys
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| BKG 1
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| Number Not Used
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| Vol #:
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| 1
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|
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| NAL
1
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| FDA
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| Vol #:
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| 1
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|
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| SS
1
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| Supporting Statement
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| Vol #:
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| 1
|
|
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| 2003P-0126
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| Refrain from approving (ANDA)for Levothyroxine Sodium Tablet
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|
|
| C
4
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| Jones Pharma, Inc. (Jones)
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| Vol #:
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| 4
|
|
|
| SUP
7
Letter, Enclosure
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| Abbott Laboratories
|
| Vol #:
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| 4
|
|
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| 2003P-0270
|
| Prohibit False and Misleading Labeling
|
|
|
| C 79
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| S. Brown
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| Vol #:
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| 9
|
|
|
| 2003P-0357
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| 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
|
|
|
|
|
|
| PAV
1
|
| HFD-001 to Beth Rosenshein
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| Vol #:
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| 1
|
|
|
| 2003P-0387
|
| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
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|
|
| C
4
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| Jones Pharma, Inc. (Jones)
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| Vol #:
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| 5
|
|
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| SUP
8
Letter, Enclosure
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| Abbott Laboratories
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| Vol #:
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| 5
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|
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| 2003P-0564
|
| 513(f) Reclassification Petition for In Vitro Diagnostics for Anti-Hepatitis A Virus IgM and Total Antibodies
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| BKG 1
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| References 1 - 10
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| Vol #:
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| 1
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| NPR
1
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| FDA
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| Vol #:
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| 1
|
|
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| 2004D-0385
|
| Class II Special Controls Guidance Document: Hepatitis A Serological Assays for the Clinical Laboratory Diagnosis of Hepatitis A Virus
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|
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| GDL
1
|
| Guideline
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| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004M-0145
|
| P020006 - Enteryx Procedure Kit, Approved 4/22/03
|
|
|
| N
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004M-0147
|
| P890064/S009 - Digene Hybrid Capture 2 (HC2) High-Risk HPV DNA Test
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|
|
| N
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004M-0165
|
| H020008; OP-1 Putty
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|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004M-0199
|
| P030032 - Hylaform (hylan B gel)
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004M-0200
|
| P010014 - Oxford Meniscal Unicompartmental Knee System
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004M-0207
|
| P970027 - Abbott AxSYM Anti-HCV
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004M-0248
|
| P030023 - Oculaid Capsular Tension Ring (Model 275 10/12 mm and Model 276 11/13 mm)
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004M-0249
|
| P000054 - INFUSE Bone Graft
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004M-0250
|
| P030035 - St. Jude Frontier Biventricular Cardiac Pacing System including the Frontier Model 5508 and 5508L Pulse Generators, the Aescula LV Model 1055K Lead and the Model 3307 v4.4.2m programmer so
|
|
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004M-0253
|
| P980007 - AxSYM Free PSA
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004M-0256
|
| Advanced Bionics; Premarket Approval for Precision Spinal Cord Stimulation (SCS) System; P030017.
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004M-0259
|
| P030045 -IntraStent DoubleStrut Stent
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|
|
| N
1
|
| FDA
|
| Vol #:
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| 1
|
|
|
| 2004M-0260
|
| P010062 - Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004N-0017
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Pilot Program for Medical Devices
|
|
| | | | | | | | |
|
|
| 2004P-0139
|
| approval of generic versions of Concerta (methylphenidate HCI extended-release tablets are both bioequivalent and clinically equivalent to the innovator product
|
|
|
| CR
1
|
| McNeil Consumer & Specialty Pharmaceuticals
|
| Vol #:
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| 8
|
|
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| 2004P-0162
|
| Zoloft (sertaline hydrochloride) Tablets 150 mg and 200 mg
|
|
|
| LET
1
|
| HFD-007 to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2004P-0202
|
| Notify State & Federal regulators of GRAS requirements of milk protein Concentrate
|
|
|
| C
9
|
| California Farmers Union
|
| Vol #:
|
| 1
|
|
|
| 2004P-0386
|
| Reject New Drug Application 21-695
|
|
|
| C
1
Tab
1
|
| Reliant Pharmaceuticals, Inc. (Reliant)
|
| Vol #:
|
| 2
|
|
|
| 2004S-0233
|
| Stimulating Innovation in Medical Technologies
|
|
|
| C
18
|
| Amgen
|
| Vol #:
|
| 2
|
|