| | | | | |
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| Dockets Entered
On July 12, 2004
Table of Contents
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| Docket #
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| Title
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| 1982N-0166
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| OTC Drug Products for Overindulgence of Alcohol
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|
|
| 1994P-0390
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| Adopt Amendments Governing Health Claims & Nutrient Claims
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|
|
| 1995P-0241
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| Implied Nutrient Content Claim 'Healthy' & Health Claims
|
|
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| 1997S-0163
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| Dietary Supplements, Courtesy Letters (Letters of Objection)
|
|
|
| 1998P-0610
|
| Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC
|
|
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| 1999P-5106
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| Identify Sources of Natural Flavorings
|
|
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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|
|
| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
|
|
| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
|
|
|
| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
|
|
|
| 2003D-0206
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| Draft Guidance for Industry on Exocrine Pancreatic Insufficiency Drug Products; Availability
|
|
|
| 2003D-0290
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| Compounding of Drugs for Use in Animals Compliance Policy Guide
|
|
|
| 2003D-0571
|
| Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information
|
|
|
| 2003E-0249
|
| Patent Extension for Elitek (rasburicase) 5,382,518
|
|
|
| 2003P-0291
|
| Enforce the law and prevent unlaw sale of contact lens
|
|
|
| 2003P-0505
|
| ANDA for Acetaminophen, Caffeine and Orphenadrine Citrate Tablets
|
|
|
| 2004D-0182
|
| Guidance for Industry on Combination Products, Timeliness of Premarket Review, Dispute Resolution
|
|
|
| 2004D-0187
|
| Guidance for Industry on Premarketing Risk Assessment
|
|
|
| 2004D-0188
|
| Guidance for Industry on Development and Use of Risk Minimization Action Plans
|
|
|
| 2004D-0189
|
| Guidance for Industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
|
|
|
| 2004N-0049
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
|
|
| 2004N-0103
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Special Protocol Assessment
|
|
|
| 2004N-0132
|
| Agency Information Collection Activities: Proposed Collection; Comment Request: Premarket Approval of Medical Devices
|
|
|
| 2004N-0133
|
| Part 11, Electronic Record; Electronic Signatures; Public Meeting
|
|
|
| 2004N-0161
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Information from U.S. Processors that Export to the European Community
|
|
|
| 2004N-0181
|
| Critical Path Initiative
|
|
|
| 2004N-0234
|
| Annual Guidance Agenda
|
|
|
| 2004N-0275
|
| Agency Emergency Processing Under OMB Review; Application for Participation in the Medical Device Fellowship Program; Form FDA 3608
|
|
|
| 2004P-0013
|
| Review safety of Nutropin Depot Injection, issue direction to Genentech Inc. to add warnings regarding diabetes in their safety literature, and consider amending 21 CFR 314.80(e) Postmarketing studies
|
|
|
|
|
|
| 2004P-0015
|
| Deny approval of any New Drug Application ( NDA ) for recombinant salmon calcitonin (rsCT ) nasal spray
|
|
|
| 2004P-0056
|
| ANDA for Ondansetron Orally Disintegrating Tablets
|
|
|
| 2004P-0069
|
| Declare that Fentanyl Transdermal Systems, in strengths of 37.5 mcg/hr, 62.5 mcg/hr, and 87.5 mcg/hr are suitable for submission in an ANDA
|
|
|
| 2004P-0123
|
| Glimepiride Tablets, 3mg and 6mg for an Abbreviated new drug application ( ANDA )
|
|
|
| 2004P-0293
|
| Carbohydrate Labeling - Remove Dietary Fiber from Total Carbohydrates
|
|
|
| 2004P-0294
|
| Health Claim Petition: Noncariogenicity Dental Health Claim for Sucralose
|
|
|
| 2004P-0295
|
| To determine whether Zyvox (linezolid) tablets 400mg (NDA 20-130) has been withdrawn for safety or effectiveness reasons as outlined below.
|
|
| | | | | | | | |
|
|
| 2004Q-0097
|
| Qualified Health Claim: Calcium and various cancers
|
|
|
| 2004Q-0098
|
| Qualified Health Claim: Calcium and hypertension
|
|
|
| 2004Q-0099
|
| Qualified Health Claim: Calcium and menstrual disorders
|
|
|
| 2004Q-0100
|
| Qualified Health Claim: Calcium and bone fractures
|
|
|
| 2004Q-0102
|
| Qualified Health Claim: Calcium and Kidney/urinary stones
|
|
|
| 2004Q-0180
|
| Qualified Health Claim (QHC): Lutein and Eye Diseases
|
|
|
| 2004S-0170
|
| Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research
|
|
|
| 1982N-0166
|
| OTC Drug Products for Overindulgence of Alcohol
|
|
|
| SUP 4
|
| Procter & Gamble Company (P&G)
|
| Vol #:
|
| 22
|
|
|
| 1994P-0390
|
| Adopt Amendments Governing Health Claims & Nutrient Claims
|
|
|
| EMC 2
|
| National Nutritional Foods Assn (NNFA)
|
| Vol #:
|
| 7
|
|
|
| EMC 3
Attachment
|
| American Feed Industry Assn (AFIA)
|
| Vol #:
|
| 7
|
|
|
| EMC 4
|
| American Heart Assn Assn
|
| Vol #:
|
| 7
|
|
|
| EMC 5
|
| Kellogg's
|
| Vol #:
|
| 7
|
|
|
| EMC 6
|
| Natonal Dairy Council (NDC)
|
| Vol #:
|
| 7
|
|
|
| 1995P-0241
|
| Implied Nutrient Content Claim 'Healthy' & Health Claims
|
|
|
| EMC 2
|
| National Nutritional Foods Assn (NNFA)
|
| Vol #:
|
| 9
|
|
|
| EMC 3
Attachment
|
| American Feed Industry Assn (AFIA)
|
| Vol #:
|
| 9
|
|
|
| EMC 4
|
| American Heart Assn
|
| Vol #:
|
| 9
|
|
|
| EMC 5
|
| Kellogg
|
| Vol #:
|
| 9
|
|
|
| EMC 6
|
| National Dairy Council (NDC)
|
| Vol #:
|
| 9
|
|
|
| 1997S-0163
|
| Dietary Supplements, Courtesy Letters (Letters of Objection)
|
|
|
| LET 760
|
| HFS-800 to Banks of Eden LLC
|
| Vol #:
|
| 23
|
|
|
| LET 761
|
| HFS-800 to Herb Pharm
|
| Vol #:
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| 23
|
|
|
| LET 762
|
| HFS-800 to Waleda Inc
|
| Vol #:
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| 23
|
|
|
| 1998P-0610
|
| Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC
|
|
| EMC 102
|
| Wellpoint
|
| Vol #:
|
| 6
|
|
|
| 1999P-5106
|
| Identify Sources of Natural Flavorings
|
|
|
| EMC 163
|
| E. Leckar
|
| Vol #:
|
| 2
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
|
|
| EXB 244
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 419
|
|
|
| EXB 245
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 419
|
|
| | | | | | | | |
|
|
| EXB 246
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 419
|
|
|
| EXB 247
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 419
|
|
|
| EXB 248
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 419
|
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
|
|
| EMC 182
|
| C. Eubank
|
| Vol #:
|
| 3
|
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
|
|
| C 351
|
| Japan Airlines International Co., Ltd (JAL)
|
| Vol #:
|
| 29
|
|
|
| C 352
|
| Scotch Whisky Assn
|
| Vol #:
|
| 29
|
|
|
| EMC 211
Attachment
|
| Canadian Maufacturers & Exporters
|
| Vol #:
|
| 29
|
|
|
| EMC 212
|
| Baskets By Geri's Eatin' Centre
|
| Vol #:
|
| 29
|
|
|
| MM 13
|
| Meeting Between FDA and CBP,CFIA and Canadian Boeder Services Agency
|
| Vol #:
|
| 29
|
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
|
| EMC 342
|
| Mission Possible Intl.
|
| Vol #:
|
| 6
|
|
|
| EMC 343
|
| R. Murray
|
| Vol #:
|
| 6
|
|
|
| EMC 344
|
| J. Bowen, MD
|
| Vol #:
|
| 6
|
|
|
| EMC 345
|
| Mission Possible International
|
| Vol #:
|
| 6
|
|
|
| EMC 346
|
| Mission Possible International
|
| Vol #:
|
| 6
|
|
|
| 2003D-0206
|
| Draft Guidance for Industry on Exocrine Pancreatic Insufficiency Drug Products; Availability
|
|
|
| C 9
|
| Australian Government
|
| Vol #:
|
| 1
|
|
|
| EC 8
|
| Digestive Care, Inc.
|
| Vol #:
|
| 1
|
|
|
| EC 9
|
| Digestive Care, Inc.
|
| Vol #:
|
| 1
|
|
|
| EC 10
|
| Digestive Care, Inc.
|
| Vol #:
|
| 1
|
|
|
| EC 11
|
| Digestive Care, Inc.
|
| Vol #:
|
| 1
|
|
|
| EC 12
|
| Digestive Care, Inc.
|
| Vol #:
|
| 1
|
|
|
| EC 13
|
| Cystic Fibrosis Foundation
|
| Vol #:
|
| 1
|
|
|
| EC 14
|
| Cystic Fibrosis Foundation
|
| Vol #:
|
| 1
|
|
|
| EC 15
|
| MERISTEM Therapeutics
|
| Vol #:
|
| 1
|
|
|
| EC 16
|
| CanReg Inc. on behalf of Axcan Scandipharm Inc.
|
| Vol #:
|
| 1
|
|
|
| EC 17
|
| KV Pharmaceutical Company
|
| Vol #:
|
| 1
|
|
|
| 2003D-0290
|
| Compounding of Drugs for Use in Animals Compliance Policy Guide
|
|
| C 10
|
| American Veterinary Medical Assn (AVMA)
|
| Vol #:
|
| 1
|
|
|
| 2003D-0571
|
| Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information
|
|
|
| C 25
|
| Pharmaceuticals Research and Manufacturers of America (PhRMA)
|
| Vol #:
|
| 2
|
|
| | | | | | | | |
|
|
| EMC 3
|
| Merck & Co., Inc.
|
| Vol #:
|
| 2
|
|
|
| 2003E-0249
|
| Patent Extension for Elitek (rasburicase) 5,382,518
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2003P-0291
|
| Enforce the law and prevent unlaw sale of contact lens
|
|
|
| PDN 1
|
| HFZ-1 to Timothy Milburn O.D.
|
| Vol #:
|
| 2
|
|
|
| 2003P-0505
|
| ANDA for Acetaminophen, Caffeine and Orphenadrine Citrate Tablets
|
|
|
| WDL 1
|
| Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2004D-0182
|
| Guidance for Industry on Combination Products, Timeliness of Premarket Review, Dispute Resolution
|
|
|
| C 3
|
| Pharmaceutical Research and Manfacturers of America (PhRMA)
|
| Vol #:
|
| 1
|
|
|
| 2004D-0187
|
| Guidance for Industry on Premarketing Risk Assessment
|
|
|
| C 9
|
| ISPE
|
| Vol #:
|
| 1
|
|
|
| C 10
|
| Bristol-Myers Squibb Company
|
| Vol #:
|
| 1
|
|
|
| EMC 3
|
| Centers for Education & research on Therapeutics (CERTs)
|
| Vol #:
|
| 1
|
|
|
| EMC 4
|
| Merck & Co., Inc.
|
| Vol #:
|
| 1
|
|
|
| EMC 5
Attachment
|
| Johnson and Johnson
|
| Vol #:
|
| 1
|
|
|
| 2004D-0188
|
| Guidance for Industry on Development and Use of Risk Minimization Action Plans
|
|
|
| C 9
|
| ISPE
|
| Vol #:
|
| 1
|
|
|
| C 10
|
| Bristol-Myers Squibb Company
|
| Vol #:
|
| 1
|
|
|
| EMC 5
|
| American Medical Assn (AMA)
|
| Vol #:
|
| 1
|
|
|
| EMC 6
|
| Centers for Education & Research on Therapeutics (CERTs)
|
| Vol #:
|
| 1
|
|
|
| EMC 7
|
| J. Kramer,MD,MS
|
| Vol #:
|
| 1
|
|
|
| EMC 8
|
| Merck & Co., Inc.
|
| Vol #:
|
| 1
|
|
|
| EMC 9
Attachment
|
| Johnson and Johson
|
| Vol #:
|
| 1
|
|
|
| EMC 10
|
| American Pharmacists Assn (APhA)
|
| Vol #:
|
| 1
|
|
|
| 2004D-0189
|
| Guidance for Industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
|
|
|
| C 8
|
| ISPE
|
| Vol #:
|
| 1
|
|
|
| C 9
|
| Bristol-Myers Squibb Company
|
| Vol #:
|
| 1
|
|
|
| EMC 3
|
| Centers for Education & research on therapeutics (CERTs)
|
| Vol #:
|
| 1
|
|
|
| EMC 4
|
| Merck & Co., Inc.
|
| Vol #:
|
| 1
|
|
|
| EMC 5
Attachment
|
| Johnson and Johnson
|
| Vol #:
|
| 1
|
|
|
| 2004N-0049
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
|
|
|
|
|
| | | | | | | | |
|
|
| N
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004N-0103
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Special Protocol Assessment
|
|
|
| N
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004N-0132
|
| Agency Information Collection Activities: Proposed Collection; Comment Request: Premarket Approval of Medical Devices
|
|
|
| N
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004N-0133
|
| Part 11, Electronic Record; Electronic Signatures; Public Meeting
|
|
|
| C 16
|
| National Grain and Feed Assn (NGFA)
|
| Vol #:
|
| 4
|
|
|
| C 17
|
| United Parcel Service, Inc. (UPS)
|
| Vol #:
|
| 4
|
|
|
| C 18
|
| ABB Process Solutions
|
| Vol #:
|
| 4
|
|
|
| C 19
|
| Wyeth Pharmaceuticals
|
| Vol #:
|
| 4
|
|
|
| C 20
|
| EduQuest, Inc.
|
| Vol #:
|
| 4
|
|
|
| C 21
|
| Assn of Clinical Research Organizations (ACRO)
|
| Vol #:
|
| 4
|
|
|
| C 22
|
| Dow Chemical Company (Dow)
|
| Vol #:
|
| 4
|
|
|
| C 23
|
| Gas Regs, Inc.
|
| Vol #:
|
| 4
|
|
|
| C 24
|
| Pfizer, Inc.
|
| Vol #:
|
| 4
|
|
|
| C 25
|
| Land O'Lakes Farmland Feed, LLC
|
| Vol #:
|
| 5
|
|
|
| C 26
|
| Cosmetic, Toiletry and Fragrance Assn (CTFA)
|
| Vol #:
|
| 5
|
|
|
| C 27
|
| Pharmaceutical Research and Manufacturers of America (PhRMA)
|
| Vol #:
|
| 5
|
|
|
| C 28
|
| Advanced Medical Technology Assn (AdvaMed)
|
| Vol #:
|
| 5
|
|
|
| C 29
|
| Compressed Gas Assn (CGA)
|
| Vol #:
|
| 5
|
|
|
| C 30
|
| F. Hoffmann-La Roche Ltd.
|
| Vol #:
|
| 5
|
|
|
| C 31
|
| Society of Quality Assurance (SQA)
|
| Vol #:
|
| 5
|
|
|
| C 32
|
| Bristol-Myers Squibb Company
|
| Vol #:
|
| 5
|
|
|
| C 33
|
| GlaxoSmithKline (GSK)
|
| Vol #:
|
| 5
|
|
|
| EMC 48
Attachment 1, 2
|
| ISPE
|
| Vol #:
|
| 4
|
|
|
| EMC 49
|
| PDA of Japan
|
| Vol #:
|
| 4
|
|
|
| EMC 50
|
| International Assn for Pharmaceutical Technology (APV)
|
| Vol #:
|
| 4
|
|
|
| EMC 51
|
| J. Rosendal
|
| Vol #:
|
| 4
|
|
|
| EMC 52
|
| J. Rosendal
|
| Vol #:
|
| 4
|
|
|
| EMC 53
|
| National Food Processors Assn (NFPA)
|
| Vol #:
|
| 4
|
|
|
| EMC 54
|
| PDA of Japan
|
| Vol #:
|
| 4
|
|
|
| EMC 55
|
| Janssen Pharmaceutica
|
| Vol #:
|
| 4
|
|
|
| EMC 56
|
| American Assn of Blood Banks (AABB)
|
| Vol #:
|
| 4
|
|
|
| EMC 57
|
| Merck & Co., Inc.
|
| Vol #:
|
| 4
|
|
|
| EMC 58
|
| Assn of Clinical Research Organizations (ACRO)
|
| Vol #:
|
| 4
|
|
| | | | | | | | |
|
|
| 2004N-0161
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Information from U.S. Processors that Export to the European Community
|
|
|
| N
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004N-0181
|
| Critical Path Initiative
|
|
|
| C 2
|
| MicroCal, LLC
|
| Vol #:
|
| 1
|
|
|
| 2004N-0234
|
| Annual Guidance Agenda
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004N-0275
|
| Agency Emergency Processing Under OMB Review; Application for Participation in the Medical Device Fellowship Program; Form FDA 3608
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004P-0013
|
| Review safety of Nutropin Depot Injection, issue direction to Genentech Inc. to add warnings regarding diabetes in their safety literature, and consider amending 21 CFR 314.80(e) Postmarketing studies
|
|
|
|
|
|
| LET 1
|
| HFD-005 to Edward Odland
|
| Vol #:
|
| 1
|
|
|
| 2004P-0015
|
| Deny approval of any New Drug Application ( NDA ) for recombinant salmon calcitonin (rsCT ) nasal spray
|
|
|
| LET
1
|
| HFD-005 to Buc & Beardsley
|
| Vol #:
|
| 1
|
|
|
| 2004P-0056
|
| ANDA for Ondansetron Orally Disintegrating Tablets
|
|
|
| PAV 1
|
| HFD-600 to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2004P-0069
|
| Declare that Fentanyl Transdermal Systems, in strengths of 37.5 mcg/hr, 62.5 mcg/hr, and 87.5 mcg/hr are suitable for submission in an ANDA
|
|
|
| PAV 1
|
| HFD-600 to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2004P-0123
|
| Glimepiride Tablets, 3mg and 6mg for an Abbreviated new drug application ( ANDA )
|
|
|
| PAV 1
|
| HFD-600 to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2004P-0293
|
| Carbohydrate Labeling - Remove Dietary Fiber from Total Carbohydrates
|
|
|
| ACK 1
|
| HFA-305
|
| Vol #:
|
| 1
|
|
|
| CP 1
|
| National Starch and Chemical Company
|
| Vol #:
|
| 1
|
|
|
| 2004P-0294
|
| Health Claim Petition: Noncariogenicity Dental Health Claim for Sucralose
|
|
|
| CP 1
Attachments
|
| McNeil Nutritionals, Div. of McNeil - PPC, Inc.
|
| Vol #:
|
| 1
|
|
|
| ACK 1
|
| HFS-832 to McNeil Nutritionals
|
| Vol #:
|
| 2
|
|
|
| LET 1
|
| McNeil Nutritionals
|
| Vol #:
|
| 2
|
|
|
| LET 2
|
| HFS-800 to McNeil Nutritionals
|
| Vol #:
|
| 2
|
|
|
| SUP 1
|
| McNeil Nutritionals
|
| Vol #:
|
| 2
|
|
|
| 2004P-0295
|
| To determine whether Zyvox (linezolid) tablets 400mg (NDA 20-130) has been withdrawn for safety or effectiveness reasons as outlined below.
|
|
|
| ACK 1
|
| HFA-305 to - Lachman Consultant Services Inc.
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
| CP 1
|
| Lachman Consultant Services Inc.
|
| Vol #:
|
| 1
|
|
|
| 2004Q-0097
|
| Qualified Health Claim: Calcium and various cancers
|
|
|
| LET 3
|
| Emord & Associates PC
|
| Vol #:
|
| 15
|
|
|
| 2004Q-0098
|
| Qualified Health Claim: Calcium and hypertension
|
|
|
| LET 5
|
| Emord & Associates PC
|
| Vol #:
|
| 9
|
|
|
| 2004Q-0099
|
| Qualified Health Claim: Calcium and menstrual disorders
|
|
|
| LET 3
|
| Emord & Associates PC
|
| Vol #:
|
| 4
|
|
|
| 2004Q-0100
|
| Qualified Health Claim: Calcium and bone fractures
|
|
|
| LET 3
|
| Emord & Associates PC
|
| Vol #:
|
| 6
|
|
|
| 2004Q-0102
|
| Qualified Health Claim: Calcium and Kidney/urinary stones
|
|
|
| LET 3
|
| Emord & Associates PC
|
| Vol #:
|
| 6
|
|
|
| 2004Q-0180
|
| Qualified Health Claim (QHC): Lutein and Eye Diseases
|
|
|
| C 1
|
| United Egg Producers
|
| Vol #:
|
| 5
|
|
|
| C 2
|
| United States Department of Agriculture
|
| Vol #:
|
| 5
|
|
|
| 2004S-0170
|
| Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research
|
|
|
| EMC 24
|
| Pfizer Global Pharmaceuticals
|
| Vol #:
|
| 3
|
|
|