Dockets Entered on November 9, 2004

Dockets Management



Dockets Entered On November 9, 2004 Table of Contents



Docket #	Title

1997S-0162	30-Day Structure Function Claim Notification Letters Dietary

2000D-1392	Guidance for Industry on Botanical Drug Products
2001P-0075	Switch Status of Emergency Contraceptives from Rx to OTC

2001P-0529	Request that '365 Patent Not be Re-listed in Orange Book

2004D-0343	Hospital Bed System Dimensional Guidance to Reduce Entrapment
2004D-0385	Class II Special Controls Guidance Document: Hepatitis A Serological Assays for the Clinical Laboratory Diagnosis of Hepatitis A Virus
2004D-0422	Guidance for Industry: Animal Drug Sponsor Fees Under the Animal Drug User Fee Act (ADUFA)
2004D-0443	Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations

2004N-0330	Suicidality in Clinical Trials for Antidepressant Drugs in Pediatric Patients
2004N-0454	Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
2004P-0074	oxandrolone and widely used anti-coagulant durgs containing the active drug warfarin

2004P-0223	Whole Grain Descriptive Claims

2004P-0235	Request Addition of Postmarketing Suicide Reports to the Neurontin Labeling

2004P-0349	Action on Products containing added Mercury
2004P-0472	refuse final approval to ANDA 76-258 for a generic fentanyl transdermal lsystem under it current proposed labeling
2004S-0212	Pandemic Influenza Preparedness and Response Plan

1997S-0162	30-Day Structure Function Claim Notification Letters Dietary

LET 14684	Enzymatic Therapy	Vol #:	128

LET 14685	Enzymatic Therapy	Vol #:	128

LET 14686	Enzymatic Therapy	Vol #:	128

LET 14687	Enzymatic Therapy	Vol #:	128

LET 14688	Enzymatic Therapy	Vol #:	128

LET 14689	Enzymatic Therapy	Vol #:	129

LET 14690	Enzymatic Therapy	Vol #:	129

LET 14691	Enzymatic Therapy	Vol #:	129

LET 14692	Enzymatic Therapy	Vol #:	129

LET 14693	Enzymatic Therapy	Vol #:	129

LET 14694	Enzymatic Therapy	Vol #:	129

LET 14695	Enzymatic Therapy	Vol #:	129

LET 14696	Enzymatic Therapy	Vol #:	129

LET 14697	Enzymatic Therapy	Vol #:	129

LET 14698	Enzymatic Therapy	Vol #:	129

LET 14699	Enzymatic Therapy	Vol #:	129

LET 14700	Enzymatic Therapy	Vol #:	129

LET 14701	Enzymatic Therapy	Vol #:	129

LET 14702	Enzymatic Therapy	Vol #:	129

LET 14703	Enzymatic Therapy	Vol #:	129

LET 14704	Enzymatic Therapy	Vol #:	129

LET 14705	Enzymatic Therapy	Vol #:	129

LET 14706	Enzymatic Therapy	Vol #:	129

LET 14707	Enzymatic Therapy	Vol #:	129

LET 14708	Enzymatic Therapy	Vol #:	129

LET 14709	Enzymatic Therapy	Vol #:	129



LET 14710	Herb Pharm	Vol #:	129

LET 14711	Herb Pharm	Vol #:	129

LET 14712	Ashbury Biologicals Inc.	Vol #:	129

LET 14713	Ashbury Biologicals Inc.	Vol #:	129

LET 14714	Adeeva Nutritionals Canada Inc.	Vol #:	129

LET 14715	Perrigo Company of South Carolina	Vol #:	129

LET 14716	Perrigo Company of South Carolina	Vol #:	129

LET 14717	Perrigo Company South Carolina	Vol #:	129

LET 14718	Perrigo Company of South Carolina	Vol #:	129

LET 14719	Perrigo Company of South Carolina	Vol #:	129

LET 14720	Perrigo Company of South Carolina	Vol #:	129

LET 14721	Perrigo Company of South Carolina	Vol #:	129

LET 14722	Perrigo Company of South Carolina	Vol #:	129

LET 14723	Perrigo Company of south Carolina	Vol #:	129

LET 14724	Perrigo Company of South Carolina	Vol #:	129

LET 14725	Perrigo Company of South Carolina	Vol #:	129

LET 14726	Perrigo Company of South Carolina	Vol #:	129

LET 14727	Perrigo Company of South Carolina	Vol #:	129

LET 14728	Perrigo Company of South Carolina	Vol #:	129

2000D-1392	Guidance for Industry on Botanical Drug Products

EC 6	Mrs. CARLENE UPTON	Vol #:	1

2001P-0075	Switch Status of Emergency Contraceptives from Rx to OTC

EC 822	Dr. Marla Rowe Gorosh	Vol #:	163

LET 7	HFD-5 to Pharmacists Planning Service, Inc	Vol #:	295

2001P-0529	Request that '365 Patent Not be Re-listed in Orange Book

LET 1	HFD-7 to Rothwell, Figg, Ernst & Manbeck, PC (Mylan Pharmaceuticals Inc)	Vol #:	1

2004D-0343	Hospital Bed System Dimensional Guidance to Reduce Entrapment

EC 8	Poudre Valley Hospital	Vol #:	1

EC 9	Mr. James Newton	Vol #:	1

EC 10	Texas Association of Healthcare Facilities Managem	Vol #:	1

EC 11	Valley Regional Medical Center	Vol #:	1

2004D-0385	Class II Special Controls Guidance Document: Hepatitis A Serological Assays for the Clinical Laboratory Diagnosis of Hepatitis A Virus

EC 1	Mrs. Sarah Parsons	Vol #:	1



2004D-0422	Guidance for Industry: Animal Drug Sponsor Fees Under the Animal Drug User Fee Act (ADUFA)

EC 1	Biotechnical Services, Inc.	Vol #:	1

2004D-0443	Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations

C 1	Lloyd's Register Serentec, Inc.	Vol #:	1

EC 1	Mr. Akio Miura	Vol #:	1

2004N-0330	Suicidality in Clinical Trials for Antidepressant Drugs in Pediatric Patients

EC 53	Mrs. Teresa Pate	Vol #:	2

2004N-0454	Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting

EC 1	Ms. Amy Blakeney	Vol #:	1

EC 2	Mr. R Taylor	Vol #:	1

EC 3	Dr. Thomas Wnorowski	Vol #:	1

EC 4	Dr. James Franks	Vol #:	1

EC 5	Mr. Santos Alvarez	Vol #:	1

EC 6	Dr. Robert Mitkus	Vol #:	1

EC 8	Ms. Therese Holliday	Vol #:	1

EC 9	Ms. Ashira Wendler	Vol #:	1

EC 10	Mr. KENN RAZANO	Vol #:	1

EC 11	Mr. Gil Roetman	Vol #:	1

EC 12	Mrs. Rhonda Gryspos	Vol #:	1

EC 13	Mr. steve wilson	Vol #:	1

EC 14	Mrs. Bonnie Bates	Vol #:	1

EC 15	Mr. Thomas May	Vol #:	1

EC 16	none	Vol #:	1

EC 17	Ms. Mohini Peters	Vol #:	1

EC 18	Mr. David Sim	Vol #:	1

EC 19	Mrs. Patty Murn	Vol #:	1

EC 20	Mr. Peter McGeoghegan	Vol #:	1

EC 21	Dr. Janice King	Vol #:	1

EC 22	Ms. June Perry	Vol #:	1

EC 23	Mr. William Peters	Vol #:	1

EC 24	Mrs. Donna McKnight	Vol #:	1

EC 25	Mrs. Helen Haywood	Vol #:	1

EC 26	Maryland Poison Center	Vol #:	1

EC 27	Mr. homer wright	Vol #:	1

EC 28	Mr. James Pfeifer	Vol #:	1



2004P-0074	oxandrolone and widely used anti-coagulant durgs containing the active drug warfarin

SUP 2	Savient Pharmaceuticals	Vol #:	1

2004P-0223	Whole Grain Descriptive Claims

LET 1	HFS-800 to Patton Bogas LLP	Vol #:	1

2004P-0235	Request Addition of Postmarketing Suicide Reports to the Neurontin Labeling

LET 1	HFD-5 to Finkelstein and Partners	Vol #:	1

2004P-0349	Action on Products containing added Mercury

EC 21 Attachment	Autism Healing Network	Vol #:	1

2004P-0472	refuse final approval to ANDA 76-258 for a generic fentanyl transdermal lsystem under it current proposed labeling

C 1	Drug Free America Foundation, Inc.	Vol #:	1

2004S-0212	Pandemic Influenza Preparedness and Response Plan

EC 19	Tennessee Department of Health	Vol #:	1

EC 20	GlaxoSmithKline	Vol #:	1

EC 21	Dr. Merritt Schreiber	Vol #:	1

EC 22	Dr. Merritt Schreiber	Vol #:	1

EC 23	Idaho Department of Health and Welfare	Vol #:	1

EC 24	Quidel Corporation	Vol #:	1

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FDA/Dockets Management