Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870 [E-mail Us]

DOCKETS ENTERED on December 26, 2001

TABLE OF CONTENTS

Hyper links are part of the Docket  title - not all dockets/documents are linked

NOTE:  Documents received by the Dockets Management Branch "MAY" be posted on the Internet.

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[FDA DOCKETS PAGE] [FDA HOME PAGE]  [ ITEM CODES ]
 
81N-0114 Acne drug prod for OTC human use *
99F-5522 Ionizing radiation /control of Food-borne pathogens safe use *
01N-0459 Food Labeling; Notification Procedures on Dietary Supplement *
01N-0496 Patient Profile Viewer *
01P-0379 ANDA Suitability for a Change in Dosage Form for Imuren *
01P-0441 Hydrocodone Bitartrate/Acetaminophen tablets,10mg/300mg *
01P-0442 Hydrocodone Bitartrate/Ibuprofen Tablets 10mg/200mg *
01P-0449 ANDA Suitability for Digoxin Elixir, 0.05 mg/mL *
81N-0114 Acne drug prod for OTC human use

LET 23 HFD-560 to Consumer Healthcare Products Vol#: 55

99F-5522 Ionizing radiation /control of Food-borne pathogens safe use

SUP 2 The Center for Food Safety Vol#: 1

99P-4613 Revoke the Regulation That Approved Posilac

EMC 2408 David Hennessey Vol#: 44

00D-1538 Electronic Records; Electronic Signatures, Validation

C 10 Eastman Kodak Company Vol#: 5

C 11 R.W. Johnson Pharmaceutical Research Ins Vol#: 5

C 12 Becton Dickinson Vol#: 5

C 13 Baxter Healthcare Corporation Vol#: 5

C 14 McNeil Cosumer & Speciality Pharmaceutic Vol#: 5

C 15 American Red Cross Vol#: 5

C 16 Bayer Corporation Vol#: 5

EMC 2 Triangle PEER Group Vol#: 5

EMC 3 Phase Forward Vol#: 5

00D-1543 Electronic Signatures: Glossary of Terms

C 7 Aventis Pharmaceuticals Vol#: 5

C 8 Eastman Kodak Company Vol#: 5

C 9 Roche Pharmaceuticals Vol#: 5

C 10 Becton Dickinson Vol#: 5

C 11 McNeil Consumer & Speciality Pharmaceuti Vol#: 5

C 12 Baxter Healthcare Corporation Vol#: 5

C 13 American Red Cross Vol#: 5

C 14 Bayer Corporation Vol#: 5

EMC 2 Triangle PEERS Vol#: 5

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 9181 Mike Silvester Vol#: 401

01M-0567 P010003; BioGlue Surgical Adhesive

AAV 1 CryoLife, Inc. Vol#: 1

01M-0578 P000040; Hydro ThermAblator Endometrial Ablation System

AAV 1 BEI Medical Systems Vol#: 1

01M-0579 P000053; AMS Sphincter 800 Urinary Prosthesis

AAV 1 American Medical Systems Vol#: 1

01M-0581 P010020; AMS Acticon Neosphincter

AAV 1 American Medical Systems Vol#: 1

01N-0256 Use of Opiate Analgesics in Various Patient Population inclu

EMC 193 Kent Vol#: 2

01N-0459 Food Labeling; Notification Procedures on Dietary Supplement

C 2 National Nutritional Foods Assn Vol#: 1

01N-0496 Patient Profile Viewer

APE 2 Salamandra, LLC Vol#: 1

01P-0345 Listing the color additive yellow #5 for use in food/Drug

EMC 931 Mr & Mrs Kevin Richards Vol#: 4

EMC 932 Vicki Pannebakker Vol#: 4

EMC 933 Maria Erdman Vol#: 4

EMC 934 Nola Anderson Vol#: 4

EMC 935 Thomas P. Sloan Vol#: 4

EMC 936 Elaine A. Sloan Vol#: 4

EMC 937 Patricia Normann Vol#: 4

EMC 938 Dr. Cynthia Heavener Vol#: 4

EMC 939 Mary E. Brown Vol#: 4

EMC 940 Brenda Miller Vol#: 4

01P-0379 ANDA Suitability for a Change in Dosage Form for Imuren

PAV 1 HFD-600 to AAI International Vol#: 1

01P-0441 Hydrocodone Bitartrate/Acetaminophen tablets,10mg/300mg

PAV 1 HFD-600 to Lachman Consultant Services, Vol#: 1

01P-0442 Hydrocodone Bitartrate/Ibuprofen Tablets 10mg/200mg

PAV 1 HFD-600 to Lachman Consultant Services, Vol#: 1

01P-0449 ANDA Suitability for Digoxin Elixir, 0.05 mg/mL

WDL 1 Roxane Laboratories, Inc. Vol#: 1

01V-0438 Laser Light Show

VRA 1 HFZ-300 to The Temple Club Vol#: 1

01V-0483

VRA 1 HFZ-300 to Rave Motion Pictures Vol#: 1

01V-0512 Laser light show

VRA 1 HFZ-300 to Atmosphere Productions, Inc. Vol#: 1

01V-0513

VRA 1 HFZ-300 to Empire Entertainment LLC, DBA Vol#: 1

01V-0528 Laser Light Show

VRA 1 HFZ-300 to Cherry Optical Holography Vol#: 1