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. PLEASE DO NOT include personal identifying information, i.e. date of birth, social security number, etc., in your correspondence. |
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 * |
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
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