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| Dockets Entered
On September 15, 2004
Table of Contents
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| Docket #
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| Title
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| 1976N-0080
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| LABELING FOR DIGOXIN PRODUCTS
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| 1981N-0033
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| Oral Health Care Drug Products for OTC Human Use
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| 1990N-0361M
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| Name Declaration for Protein Hydrolysates & Vegetable Broth
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| 1991N-0103
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| Fatty Acids & Heart Disease, Hlth.Claims & Label Statements
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 1999P-5106
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| Identify Sources of Natural Flavorings
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| 2000N-1610
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| Digoxin Products Oral Use;Revocation conditions marketing
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| |
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| 2002N-0434
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| Withdrawal of Certain Proposed rules & other propose action
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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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| 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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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| 2003N-0400
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| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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| 2003P-0064
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| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
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| 2003P-0270
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| Prohibit False and Misleading Labeling
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| |
|
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| 2003P-0555
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| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
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| |
|
|
| 2004D-0193
|
| Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
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| |
|
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| 2004M-0415
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| H030009 - Vertical Expandable Prosthetic Titanium Rib (VEPTR)
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| 2004N-0018
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| Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| |
|
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| 2004N-0115
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| Prescription Drug Importation Study
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| |
|
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| 2004N-0204
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| Agency Information Collection Activities; Proposed Collection; Comment Request; , Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions Part 60 (21 CFR Part 60)
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| 2004N-0230
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| Food; Current Good Manufacturing Practice Regulations; Public Meetings
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| |
|
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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-0330
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| Suicidality in Clinical Trials for Antidepressant Drugs in Pediatric Patients
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| |
|
|
| 2004P-0059
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| Health Claim Petition: Glucosamine and Chondroitin Sulfate and Osteoarthritis
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| 2004P-0113
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| immediately remove from the market rosuvastatin (Crestor-AstraZeneca) before additional cases of life-threatening rhabdomyolysis and kidney/failure damage occur
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| |
|
|
| 2004P-0122
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| Petition to Remove Category X Categorization for Estradiol in Use-in-Pregnancy Labeling
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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-0140
|
| Rescind the March 1, 2004 Dear Applicant Letter Regarding Metaxalone Labeling
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| |
|
|
| 2004P-0202
|
| Notify State & Federal regulators of GRAS requirements of milk protein Concentrate
|
| |
|
|
| 2004P-0326
|
| ANDA for Adenosine Injection, USP 3 mg/mL with 6 mL and 10 mL fill volumes
|
| |
|
|
| 2004P-0349
|
| Action on Products containing added Mercury
|
| |
|
|
| 2004P-0365
|
| Refrain from approving ANDA for Agrylin (anagrelide hydrochloride) Capsules
|
| |
|
|
| 2004P-0368
|
| Interchangeability of Medical Devices with One Another.
|
| |
|
|
| 2004V-0363
|
| Projector for a Laser Light Show
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|
| | | | | | | | |
|
| |
|
| 2004V-0364
|
| Projector for a Laser Light Show
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|
| |
|
| 1976N-0080
|
| LABELING FOR DIGOXIN PRODUCTS
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| |
|
|
| C 11
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| Lannett Company, Inc. and Liquipharm, Inc.
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| Vol #:
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| 6
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| 1981N-0033
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| Oral Health Care Drug Products for OTC Human Use
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| |
|
|
| MM 10
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| HFD-560
|
| Vol #:
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| 70
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| |
|
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| 1990N-0361M
|
| Name Declaration for Protein Hydrolysates & Vegetable Broth
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| |
|
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| C 279
|
| White Technical Research
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| Vol #:
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| 14
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| 1991N-0103
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| Fatty Acids & Heart Disease, Hlth.Claims & Label Statements
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| |
|
|
| LET 6
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| HF-40
|
| Vol #:
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| 58
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| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
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|
|
| C 7450
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| D. Hemmings
|
| Vol #:
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| 319
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| |
|
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| C 7451
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| L. Stern
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| Vol #:
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| 319
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| |
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| 1999P-5106
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| Identify Sources of Natural Flavorings
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| |
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|
| C 67
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| K. Eichelberger
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| Vol #:
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| 3
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| |
|
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| C 68
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| P. Adams
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| Vol #:
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| 3
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| |
|
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| 2000N-1610
|
| Digoxin Products Oral Use;Revocation conditions marketing
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| |
|
|
| C 5
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| Lannett Company, Inc. and Liquipharm, Inc.
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| Vol #:
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| 1
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| |
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| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
| |
|
|
| C 2026
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| M. Hofer
|
| Vol #:
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| 289
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| C 2027
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| Y. Lee
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| Vol #:
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| 289
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| C 2028
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| M. Staples
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| Vol #:
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| 289
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| C 2029
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| E. Bromley, Esq
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| Vol #:
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| 289
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| C 2030
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| K. Ronnie
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| Vol #:
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| 289
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| C 2031
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| K. Mikuliak
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| Vol #:
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| 289
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| C 2032
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| L. Knighton
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| Vol #:
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| 289
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| C 2033
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| E. Grossmann
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| Vol #:
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| 289
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| C 2034
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| A. Swanson
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| Vol #:
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| 289
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| C 2035
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| S. Bruno
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| Vol #:
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| 289
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| |
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| C 2036
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| L. Charlot
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| Vol #:
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| 289
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| 2002N-0434
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| Withdrawal of Certain Proposed rules & other propose action
|
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| | | | | | | | |
|
| |
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| C 30
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| White Technical Research
|
| Vol #:
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| 1
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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
|
| |
|
|
| LET 7
Exhibit
1, 2
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| Henry E. Schwartz LLC
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| Vol #:
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| 4
|
| |
|
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| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
| |
|
|
| EMC 360
|
| M. Schara, RM (NRM), RAC-C (AANAC)
|
| Vol #:
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| 8
|
| |
|
|
| EMC 361
|
| M. Jak
|
| Vol #:
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| 8
|
| |
|
|
| EMC 362
|
| W. Ray
|
| Vol #:
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| 8
|
| |
|
|
| EMC 363
|
| W. Ray
|
| Vol #:
|
| 8
|
| |
|
|
| EMC 364
|
| R and J Zonzini
|
| Vol #:
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| 8
|
| |
|
|
| EMC 365
|
| M. McConnell
|
| Vol #:
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| 8
|
| |
|
|
| EMC 366
|
| G. Bryant
|
| Vol #:
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| 8
|
| |
|
|
| EMC 367
|
| A. Palmer
|
| Vol #:
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| 8
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| |
|
|
| EMC 368
|
| A. Lawrence
|
| Vol #:
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| 8
|
| |
|
|
| EMC 369
|
| S. Harrington
|
| Vol #:
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| 8
|
| |
|
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| 2003N-0312
|
| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
|
| |
|
|
| C 7
|
| Land O'Lakes Farmland Feed, LLC (LOLFL)
|
| Vol #:
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| 4
|
| |
|
|
| 2003N-0400
|
| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
| |
|
|
| EMC 54
|
| No signature
|
| Vol #:
|
| 15
|
| |
|
|
| 2003P-0064
|
| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
|
| |
|
|
| EMC 1
|
| Teva Pharmaceuticals USA, Inc. (TEVA)
|
| Vol #:
|
| 3
|
| |
|
|
| 2003P-0270
|
| Prohibit False and Misleading Labeling
|
| |
|
|
| C 78
|
| D. Fahmy
|
| Vol #:
|
| 6
|
| |
|
|
| 2003P-0555
|
| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
|
| |
|
|
| LET 2
|
| HFZ-1 to Committee for Truth in Psychiatry
|
| Vol #:
|
| 2
|
| |
|
|
| 2004D-0193
|
| Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
|
| |
|
|
| EMC 288
|
| J. Daley
|
| Vol #:
|
| 5
|
| |
|
|
| 2004M-0415
|
| H030009 - Vertical Expandable Prosthetic Titanium Rib (VEPTR)
|
| |
|
|
| AAV 1
|
| Synthes (USA)
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0018
|
| Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
|
| |
|
|
| C 4
|
| AstraZeneca, LP
|
| Vol #:
|
| 1
|
| |
|
|
| C 5
|
| Pharmaceutical Research and Manufacturers of America (PhRMA)
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| C 6
|
| Merck & Co., Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 3
|
| Public Citizen's Health Research Group
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 4
|
| D. Bratt, CMT,MD,MPH
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0081
|
| BSE Risk Materials in Foods and Cosmetics
|
| |
|
|
| C 6
|
| Hymed Group Corporation
|
| Vol #:
|
| 8
|
| |
|
|
| 2004N-0115
|
| Prescription Drug Importation Study
|
| |
|
|
| SUP 1
|
| Lulac Council #4826
|
| Vol #:
|
| 19
|
| |
|
|
| 2004N-0204
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; , Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions Part 60 (21 CFR Part 60)
|
|
|
|
|
|
|
|
|
| EMC 1
|
| B. Sachau
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0230
|
| Food; Current Good Manufacturing Practice Regulations; Public Meetings
|
| |
|
|
| C 1
|
| Juice Products Assn (JPA)
|
| Vol #:
|
| 1
|
| |
|
|
| C 2
|
| Assn for Dressings and Sauces (ADS)
|
| Vol #:
|
| 1
|
| |
|
|
| C 3
|
| Center for Science in the Public Interest (CSPI)
|
| Vol #:
|
| 1
|
| |
|
|
| C 4
Attachment
|
| Pall Corporation (Pall)
|
| Vol #:
|
| 1
|
| |
|
|
| C 5
Attachment 1,
2
|
| National Food Processors Assn (NFPA)
|
| Vol #:
|
| 1
|
| |
|
|
| C 6
|
| Vinegar Institute (VI)
|
| Vol #:
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| 1
|
| |
|
|
| C 7
|
| American Frozen Food Institute (AFFI)
|
| Vol #:
|
| 1
|
| |
|
|
| C 8
|
| National Nutritional Foods Assn (NNFA)
|
| Vol #:
|
| 1
|
| |
|
|
| C 9
|
| Food Allergy & Anaphylaxis Network (FAAN)
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 5
|
| United Fresh Fruit and Vegetable Assn (United)
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0264
|
| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
|
| |
|
|
| C 133
|
| A. Sigurdson
|
| Vol #:
|
| 22
|
| |
|
|
| C 134
|
| American Assn of Meat Processors (AAMP)
|
| Vol #:
|
| 22
|
| |
|
|
| C 135
|
| R. Claypool
|
| Vol #:
|
| 22
|
| |
|
|
| EMC 1401
|
| T. Brooks
|
| Vol #:
|
| 19
|
| |
|
|
| EMC 1402
|
| Dr. G. Pusillo
|
| Vol #:
|
| 19
|
| |
|
|
| EMC 1403
|
| A. Sigurdson
|
| Vol #:
|
| 19
|
| |
|
|
| EMC 1404
|
| L. Detwiler, DVM et al.
|
| Vol #:
|
| 19
|
| |
|
|
| EMC 1405
|
| L. Forbes
|
| Vol #:
|
| 19
|
| |
|
|
| EMC 1406
|
| A. Robertson
|
| Vol #:
|
| 19
|
| |
|
|
| EMC 1407
|
| R. Merritt
|
| Vol #:
|
| 19
|
| |
|
|
| EMC 1408
|
| D. Alstyne et al.
|
| Vol #:
|
| 19
|
| |
|
|
| EMC 1409
|
| C. Embree
|
| Vol #:
|
| 19
|
|
| | | | | | | | |
|
| |
|
| EMC 1410
|
| L. Gandolfo
|
| Vol #:
|
| 19
|
| |
|
|
| EMC 1411
|
| L. Cado
|
| Vol #:
|
| 19
|
| |
|
|
| EMC 1412
|
| D. Eckley, PhD
|
| Vol #:
|
| 19
|
| |
|
|
| 2004N-0330
|
| Suicidality in Clinical Trials for Antidepressant Drugs in Pediatric Patients
|
| |
|
|
| C 3
|
| S. Stone
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0059
|
| Health Claim Petition: Glucosamine and Chondroitin Sulfate and Osteoarthritis
|
| |
|
|
| SUP 8
CV
|
| Emord & Associates, PC
|
| Vol #:
|
| 13
|
| |
|
|
| 2004P-0113
|
| immediately remove from the market rosuvastatin (Crestor-AstraZeneca) before additional cases of life-threatening rhabdomyolysis and kidney/failure damage occur
|
| |
|
|
| LET 1
|
| HFD-005 to Public Citizen Health Research Group
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0122
|
| Petition to Remove Category X Categorization for Estradiol in Use-in-Pregnancy Labeling
|
| |
|
|
| LET 1
|
| HFD-005 to University of Medicine and Dentistry of New Jersey
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0139
|
| approval of generic versions of Concerta (methylphenidate HCI extended-release tablets are both bioequivalent and clinically equivalent to the innovator product
|
| |
|
|
| LET 1
|
| HFD-005 to McNeil Consumer & Specialty Pharmaceuticals
|
| Vol #:
|
| 4
|
| |
|
|
| 2004P-0140
|
| Rescind the March 1, 2004 Dear Applicant Letter Regarding Metaxalone Labeling
|
| |
|
|
| LET 2
|
| HFD-005 to Kleinfeld, Kaplan and Becker, LLP
|
| Vol #:
|
| 5
|
|
| |
|
| 2004P-0202
|
| Notify State & Federal regulators of GRAS requirements of milk protein Concentrate
|
| |
|
|
| EMC 7
|
| B. McLeod
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0326
|
| ANDA for Adenosine Injection, USP 3 mg/mL with 6 mL and 10 mL fill volumes
|
| |
|
|
| C 1
|
| Fujisawa Healthcare, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0349
|
| Action on Products containing added Mercury
|
| |
|
|
| C 2
|
| Blue Ridge Children's Center
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0365
|
| Refrain from approving ANDA for Agrylin (anagrelide hydrochloride) Capsules
|
| |
|
|
| C 1
References
|
| Mylan Pharmaceuticals, Inc. (Mylan)
|
| Vol #:
|
| 2
|
| |
|
|
| 2004P-0368
|
| Interchangeability of Medical Devices with One Another.
|
| |
|
|
| LET 1
|
| Barbara A. Weintraub, RN, MSN, CEN
|
| Vol #:
|
| 1
|
| |
|
|
| 2004V-0363
|
| Projector for a Laser Light Show
|
| |
|
|
| VRA 1
Attachment A,
B
|
| HFZ-300 to Timothy A. Ulatowski
|
| Vol #:
|
| 1
|
| |
|
|
| 2004V-0364
|
| Projector for a Laser Light Show
|
| |
|
|
| VRA 1
Attachment A,
B
|
| HFZ-300 to Prouducciones Latino
|
| Vol #:
|
| 1
|
|
|
