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| Dockets Entered
On March 21, 2006
Table of Contents
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| Docket #
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| Title
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| 1991F-0457
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| Safe use of Glycerides and Polyethylene Glycol Esters
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| |
|
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| 1992V-0331
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| Laser Light Show
|
| |
|
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| |
|
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| 1997S-0163
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| Dietary Supplements, Courtesy Letters (Letters of Objection)
|
| |
|
|
| 1999N-4282
|
| Biotechnology in the Year 2000 and Beyond; Public Meetings
|
| |
|
|
| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
|
| |
|
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| |
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| |
|
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
|
| |
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| 2002N-0534
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| Medical Device User Fee and Modernization Act of 2002
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| |
|
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
|
| |
|
|
| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| |
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| 2003P-0064
|
| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
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| |
|
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| 2003P-0453
|
| Abbreviated new drug applications (ANDAs) suitability for hydrocodone bitartrate
|
| |
|
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| 2003P-0544
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| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
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| |
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| 2004P-0074
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| oxandrolone and widely used anti-coagulant durgs containing the active drug warfarin
|
| |
|
|
| 2004P-0360
|
| ANDA drug Ferrlecit Injection 5 ml/62.5 mg of elemental iron
|
| |
|
|
| 2004P-0464
|
| Vitamin D and Calcium and Reduced Risk of Osteoporosis
|
| |
|
|
| 2005D-0069
|
| Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems
|
| |
|
|
| 2005D-0286
|
| Draft Guidance for Industry on INDs Approaches to Complying with CGMP During Phase 1; Availability
|
| |
|
|
| 2005D-0334
|
| Guidance for Industry on the Pediatric Research Equity Act
|
| |
|
|
| 2005D-0468
|
| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays
|
| |
|
|
| 2005D-0481
|
| Guidance for Industry, Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement Policy, Availability; and draft supporting document, Supporting Do
|
|
|
|
|
|
|
|
|
| 2005E-0251
|
| Patent Extension Application for Mycamine (micafungin sodium)(NDA 21-506), U.S. Patent No. 5,376,634
|
| |
|
|
| 2005H-0271
|
| Civil Money Penalty: TMJ Implants, Inc.
|
| |
|
|
| 2005N-0262
|
| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
|
| |
|
|
| 2005N-0285
|
| Current Good Manufacturing Practice Regulation and Investigational New Drugs
|
| |
|
|
| 2005P-0360
|
| salmon calcitonin products unless certain conditions are met FDA should not approved
|
| |
|
|
| 2005P-0377
|
| Petition to Rescind the "Generally Recognized as Safe" or GRAS Status for Aluminum Based Food Additives
|
| |
|
|
| 2005P-0383
|
| refuse to approve any ANDA for generic oral products containing oxandrolone until the expiration od that exclusitity peroid on June 20, 2008.
|
| |
|
|
| 2005P-0405
|
| Reclassification for Metal/Metal Semiconstrained Hip Joint Prostheses with Cemented or Uncemented Acetabular Components
|
| |
|
|
| 2005P-0409
|
| Refuse Approval of NDA for Olopatadine Hydrochloride Nasal Spray
|
| |
|
|
| 2005P-0417
|
| ANDA for Tretinoin Cream Drug Products in Strengths of 0.0375% and 0.075%
|
| |
|
|
| 2005P-0436
|
| ADA 21-863' Ibuprogen Liquid filled gelatin capsules 200 mg; Ranbaxy Laboratories, Ltd.
|
| |
|
|
| 2006D-0066
|
| Guidance for Industry and FDA Staff: Whole Grains Label Statements
|
| |
|
|
| 2006E-0004
|
| Patent Extension Application for CYMBALTA (duloxetine hydrochloride), U.S. Patent No. 5,023,269
|
|
| | | | | | | | |
| |
|
|
| 2006E-0042
|
| Patent Extension Application for CUBICIN (daptomycin for injection), U.S. Patent No. 4,885,243
|
| |
|
|
| 2006P-0047
|
| Refrain from Approval any ANDA for Celestone Soluspan
|
| |
|
|
| 2006P-0068
|
| Determine whether Syntocinon (oxytocin) Nasal Spray NDA 12-285, has been voluntarily withdrawn for safety or effectiveness reasons
|
| |
|
|
| 2006P-0094
|
| To undertake rulemaking to establish specific rules and regulations governing the definition of natural before a natural claim can be made on foods and beverages regulated by the FDA
|
| |
|
|
| 1991F-0457
|
| Safe use of Glycerides and Polyethylene Glycol Esters
|
| |
|
|
| OB 1
|
| R. Dudrick
|
| Vol #:
|
| 1
|
| |
|
|
| OB 2
|
| B. Sachau
|
| Vol #:
|
| 1
|
|
| |
|
| 1992V-0331
|
| Laser Light Show
|
| |
|
|
| EXP 5
|
| Advanced Entertainment Technologies
|
| Vol #:
|
| 1
|
| |
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| LET 17294
|
| NBTY Inc.
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17295
|
| NBTY Inc.
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17296
|
| NBTY Inc.
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17297
|
| NDS Nutritional Products, Inc.
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17298
|
| Enzymatic Therapy
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17299
|
| CNS, Inc.
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17300
|
| Oregon's Wild Harvest
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17301
|
| Enzymatic Therapy
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17302
|
| Enzymatic Therapy
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17303
|
| Enzymatic Therapy
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17304
|
| Enzymatic Therapy
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17305
|
| Enzymatic Therapy
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17306
|
| Enzymatic Therapy
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17307
|
| Enzymatic Therapy
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17308
|
| Enzymatic Therapy
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17309
|
| Enzymatic Therapy
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17310
|
| Enzymatic Therapy
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17311
|
| Enzymatic Therapy
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17312
|
| Gaia Herbs
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17313
|
| Brownwood Acres Foods Inc./Flavonoid Sciences
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17314
|
| Weeks & Leo Co., Inc.
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17315
|
| Personal Best, Inc.
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17316
|
| Atrium Biotechnologies Inc.
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17317
|
| Univera, Inc. d.b.a. Oasis LifeSciences
|
| Vol #:
|
| 158
|
|
| | | | | | | | |
| |
|
|
| LET 17318
|
| Univera, Inc.,d.b.a. Oasis LifeSciences
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17319
|
| Tabak's Health Products
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17320
|
| Ortho Molecular Products, Inc.
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17321
|
| Ortho Molecular Products, Inc.
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17322
|
| Ortho Molecular Products, Inc.
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17323
|
| Ortho Molecular Products,Inc.
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17324
|
| Metagenics, Inc.
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17325
|
| Shaklee Corporation
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17326
|
| Shaklee Corporation
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17327
|
| Shaklee Corporation
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17328
|
| LaneLabs USA, Inc.
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17329
|
| LaneLabs USA, Inc.
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17330
|
| LaneLabs USA, Inc.
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17331
|
| LaneLabs USA, Inc.
|
| Vol #:
|
| 158
|
| |
|
|
| LET 17332
|
| LaneLabs USA, Inc.
|
| Vol #:
|
| 159
|
| |
|
|
| LET 17333
|
| LaneLabs USA, Inc.
|
| Vol #:
|
| 159
|
| |
|
|
| LET 17334
|
| LaneLabs USA, Inc.
|
| Vol #:
|
| 159
|
| |
|
|
| LET 17335
|
| Enzymatic Therapy
|
| Vol #:
|
| 159
|
| |
|
|
| LET 17336
|
| Greek Island Labs, LLC
|
| Vol #:
|
| 159
|
| |
|
|
| LET 17337
|
| Enzymatic Therapy
|
| Vol #:
|
| 159
|
| |
|
|
| LET 17338
|
| Enzymatic Therapy
|
| Vol #:
|
| 159
|
| |
|
|
| LET 17339
|
| Enzymatic Therapy
|
| Vol #:
|
| 159
|
| |
|
|
| LET 17340
|
| Enzymatic Therapy
|
| Vol #:
|
| 159
|
| |
|
|
| LET 17341
|
| Pure Encapsulations
|
| Vol #:
|
| 159
|
| |
|
|
| LET 17342
|
| Don Ford, M.D.
|
| Vol #:
|
| 159
|
| |
|
|
| 1997S-0163
|
| Dietary Supplements, Courtesy Letters (Letters of Objection)
|
| |
|
|
| LET 863
|
| FDA/CFSAN to Arkopharma, LLC dba Health From the Sun
|
| Vol #:
|
| 26
|
| |
|
|
| LET 864
|
| FDA/CFSAN to RKS Inc
|
| Vol #:
|
| 26
|
| |
|
|
| LET 865
|
| FDA/CFSAN to Natural Factors Nutritional Products Inc
|
| Vol #:
|
| 26
|
| |
|
|
| LET 866
|
| FDA/CFSAN to NutraVital Inc
|
| Vol #:
|
| 26
|
| |
|
|
| LET 867
|
| FDA/CFSAN to Gindan Neutra-Ceuticals, Inc
|
| Vol #:
|
| 26
|
| |
|
|
| LET 868
|
| FDA/CFSAN to Jarrow Formulas Inc
|
| Vol #:
|
| 26
|
| |
|
|
| LET 869
|
| FDA/CFSAN to RKS, Inc
|
| Vol #:
|
| 26
|
| |
|
|
| 1999N-4282
|
| Biotechnology in the Year 2000 and Beyond; Public Meetings
|
| |
|
|
| C 18256
|
| S. Gordon
|
| Vol #:
|
| 516
|
|
| | | | | | | | |
|
| |
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
| |
|
|
| EMC 632
|
| R. Mattingly
|
| Vol #:
|
| 24
|
| |
|
|
| EMC 633
|
| R. Swan
|
| Vol #:
|
| 24
|
| |
|
|
| EMC 634
|
| J. Macha
|
| Vol #:
|
| 24
|
| |
|
|
| 2000P-1211
|
| Establish Mandatory Pre-Market Safety Testing for GE Foods
|
| |
|
|
| C 12849
|
| S. Gordon
|
| Vol #:
|
| 806
|
| |
|
|
| 2001P-0230
|
| Domestic Marketing & Importation of Transgenic Fish
|
| |
|
|
| C 1373
|
| C. Becker
|
| Vol #:
|
| 259
|
| |
|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
| |
|
|
| EMC 1314
|
| K. Kemp
|
| Vol #:
|
| 6
|
| |
|
|
| 2002N-0534
|
| Medical Device User Fee and Modernization Act of 2002
|
| |
|
|
| EMC 9
|
| America's Health Insurance Plans (AHIP)
|
| Vol #:
|
| 2
|
| |
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
| |
|
|
| EMC 616
|
| Dr. B. Martini, D. Hum.
|
| Vol #:
|
| 9
|
| |
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
| |
|
|
| EMC 1251
|
| A. Jones
|
| Vol #:
|
| 12
|
| |
|
|
| EMC 1252
|
| Christian
|
| Vol #:
|
| 12
|
| |
|
|
| EMC 1253
|
| L. Siebert, RN, MPH
|
| Vol #:
|
| 12
|
| |
|
|
| 2003P-0064
|
| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
|
| |
|
|
| C 9
|
| sanofi-aventis US LLC
|
| Vol #:
|
| 6
|
| |
|
|
| 2003P-0453
|
| Abbreviated new drug applications (ANDAs) suitability for hydrocodone bitartrate
|
| |
|
|
| PDN 1
|
| HFD-600 to King & Spalding LLP
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0544
|
| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
|
| |
|
|
| C 52
|
| S. Gordon
|
| Vol #:
|
| 5
|
| |
|
|
| 2004P-0074
|
| oxandrolone and widely used anti-coagulant durgs containing the active drug warfarin
|
| |
|
|
| C 7
|
| D. Lowe
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0360
|
| ANDA drug Ferrlecit Injection 5 ml/62.5 mg of elemental iron
|
| |
|
|
| PAV 1
|
| HFD-600 to AAC Consulting Group
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0464
|
| Vitamin D and Calcium and Reduced Risk of Osteoporosis
|
|
| | | | | | | | |
| |
|
|
| M 1
|
| Federalism Notice to States for Vitamin D/Calcium Health Claim Regulation
|
| Vol #:
|
| 9
|
| |
|
|
| 2005D-0069
|
| Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems
|
| |
|
|
| EC 2
|
| Number not used
|
| Vol #:
|
| 1
|
| |
|
|
| 2005D-0286
|
| Draft Guidance for Industry on INDs Approaches to Complying with CGMP During Phase 1; Availability
|
| |
|
|
| C 3
|
| Cambrex Corporation
|
| Vol #:
|
| 1
|
| |
|
|
| C 4
|
| Novartis Pharmaceuticals
|
| Vol #:
|
| 1
|
| |
|
|
| C 5
|
| Amgen
|
| Vol #:
|
| 1
|
| |
|
|
| C 6
|
| GE HEalthcare
|
| Vol #:
|
| 1
|
| |
|
|
| C 7
|
| Chiron Corporation
|
| Vol #:
|
| 1
|
| |
|
|
| C 8
|
| Parenteral Drug Association (PDA)
|
| Vol #:
|
| 1
|
| |
|
|
| C 9
|
| Abbott
|
| Vol #:
|
| 1
|
| |
|
|
| C 10
|
| Wyeth Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2005D-0334
|
| Guidance for Industry on the Pediatric Research Equity Act
|
| |
|
|
| C 2
|
| Association of Medical School Pediatric Department Chairs, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2005D-0468
|
| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays
|
| |
|
|
| C 1
|
| The New York Eye and Ear Infirmary
|
| Vol #:
|
| 1
|
| |
|
|
| 2005D-0481
|
| Guidance for Industry, Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement Policy, Availability; and draft supporting document, Supporting Do
|
|
|
|
|
|
|
|
|
| C 8
|
| Eligible
|
| Vol #:
|
| 1
|
| |
|
|
| 2005E-0251
|
| Patent Extension Application for Mycamine (micafungin sodium)(NDA 21-506), U.S. Patent No. 5,376,634
|
| |
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2005H-0271
|
| Civil Money Penalty: TMJ Implants, Inc.
|
| |
|
|
| MO 7
|
| TMJ Implants, Inc. and Robert W. Christensen and Maureen K Mooney
|
| Vol #:
|
| 3
|
| |
|
|
| 2005N-0262
|
| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
|
| |
|
|
| EC 10
|
| Mr. monty sims
|
| Vol #:
|
| 1
|
| |
|
|
| LET 9
|
| Pfizer, Inc.
|
| Vol #:
|
| 2
|
| |
|
|
| 2005N-0285
|
| Current Good Manufacturing Practice Regulation and Investigational New Drugs
|
| |
|
|
| C 2
|
| Abbott
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0360
|
| salmon calcitonin products unless certain conditions are met FDA should not approved
|
| |
|
|
| RC 1
|
| Foley & Lardner LLP
|
| Vol #:
|
| 1
|
|
| |
|
| 2005P-0377
|
| Petition to Rescind the "Generally Recognized as Safe" or GRAS Status for Aluminum Based Food Additives
|
|
| | | | | | | | |
| |
|
|
| LET 2
|
| HFS-200 to Department of the Planet Earth
|
| Vol #:
|
| 3
|
| |
|
|
| SUP 8
|
| Department of the Planet Earth
|
| Vol #:
|
| 3
|
|
| |
|
| 2005P-0383
|
| refuse to approve any ANDA for generic oral products containing oxandrolone until the expiration od that exclusitity peroid on June 20, 2008.
|
| |
|
|
| LET 1
|
| HFD-005 to Buchanan Ingersoll
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0405
|
| Reclassification for Metal/Metal Semiconstrained Hip Joint Prostheses with Cemented or Uncemented Acetabular Components
|
| |
|
|
| LET 2
|
| HFZ-001 to Orthopedic Surgical Manufacturers Association (OSMA)
|
| Vol #:
|
| 4
|
| |
|
|
| 2005P-0409
|
| Refuse Approval of NDA for Olopatadine Hydrochloride Nasal Spray
|
| |
|
|
| EC 1
|
| Mr. Dave Lowe
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0417
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| ANDA for Tretinoin Cream Drug Products in Strengths of 0.0375% and 0.075%
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| |
|
|
| C 2
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| D. Lowe
|
| Vol #:
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| 1
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| |
|
|
| LET 1
|
| HFD-600 to Triax Pharmaceuticals, LLC
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| Vol #:
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| 1
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| |
|
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| 2005P-0436
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| ADA 21-863' Ibuprogen Liquid filled gelatin capsules 200 mg; Ranbaxy Laboratories, Ltd.
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| |
|
|
| SUP 1
|
| Banner Pharmacaps Inc.
|
| Vol #:
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| 1
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| |
|
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| 2006D-0066
|
| Guidance for Industry and FDA Staff: Whole Grains Label Statements
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| |
|
|
| C 1
|
| C. Broxon
|
| Vol #:
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| 1
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| |
|
|
| 2006E-0004
|
| Patent Extension Application for CYMBALTA (duloxetine hydrochloride), U.S. Patent No. 5,023,269
|
| |
|
|
| C 1
|
| D. Lowe
|
| Vol #:
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| 1
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| |
|
|
| 2006E-0042
|
| Patent Extension Application for CUBICIN (daptomycin for injection), U.S. Patent No. 4,885,243
|
| |
|
|
| C 1
|
| D. Lowe
|
| Vol #:
|
| 1
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| |
|
|
| 2006P-0047
|
| Refrain from Approval any ANDA for Celestone Soluspan
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| |
|
|
| C 1
|
| D. Lowe
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0068
|
| Determine whether Syntocinon (oxytocin) Nasal Spray NDA 12-285, has been voluntarily withdrawn for safety or effectiveness reasons
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| |
|
|
| C 1
|
| D. Lowe
|
| Vol #:
|
| 1
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| |
|
|
| 2006P-0094
|
| To undertake rulemaking to establish specific rules and regulations governing the definition of natural before a natural claim can be made on foods and beverages regulated by the FDA
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| C 1
|
| Center for Science in the Public Interest (CSPI)
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| Vol #:
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| 2
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| |
|
|
| C 2
|
| H. Waltmire
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| Vol #:
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| 2
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|
