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 April 9, 2002 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. |
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94S-0120 510K Substantially Equivalent List
LST 113 List of March 2002 Vol#: 27
95N-0308 Inapplicability of the Dietary Supplement Health & Ed. Act
C 8 Sue Olmos Vol#: 1
C 9 Jackie Lucius Vol#: 1
C 10 Lisa M. Repa Vol#: 1
C 11 Gail Tucker Vol#: 1
C 12 Gina Palmer Vol#: 1
C 13 Trudi A. Kimm Vol#: 1
C 14 Pamela S. Klonaris Vol#: 1
C 15 Nora Dickins Vol#: 1
C 16 Nancy Cullinan Vol#: 1
C 17 Spring Farm Cares Vol#: 1
C 18 June L. Willoughby Vol#: 1
C 19 Lori Garrison Vol#: 1
C 20 Jennifer Vol#: 1
C 21 Maxine Brinker Vol#: 1
C 22 Hieidi L. Dumas Vol#: 1
C 23 Tereasa Steinberg Vol#: 1
C 24 Patricia M. Aussem Vol#: 1
C 26 Lara Cottrell-Springfield Vol#: 1
C 27 Barbara Renkosiewicz Vol#: 1
C 28 Yvonne M. Welz Vol#: 1
C 29 Lara Cottrell-Stringfield Vol#: 1
C 30 Diane M. Lanigan Vol#: 1
C 31 Dorothy W. Riley Vol#: 1
C 32 Ellen S. Kohn Vol#: 1
C 33 Susan Cole Vol#: 1
C 34 Rosamaria Carbonell Vol#: 1
C 35 Pet Health & Nutrition Ctr. Vol#: 1
C 36 Kristi Billinger Vol#: 1
C 37 Sharon D. Stein Vol#: 1
C 38 Karla Gunderson Vol#: 1
C 39 Diana R. Liebich Vol#: 1
C 40 Fred Liebich Vol#: 1
C 41 Elaine Burn Vol#: 1
99D-0392 Seafood HACCP transition guidance
CP 1 United Fishing Agency, Ltd. Vol#: 1
99P-2077 Reg/Guide to Label Medical Devices contain'g Phthalate Plast
EMC 11 Health Care Without Harm et al Vol#: 3
PDN 2 HFZ-1 to Health Care Without Harm Vol#: 3
00E-1238 Patent Extension Temodar (temozolomide), #5,260,291
LET 2 U.S. Patent & Trademark Office Vol#: 1
M 1 HFD-7 Vol#: 1
00E-1348 Patent Extension PROTONIX, No. 4,758,579
LET 2 U.S. Patent & Trademark Office Vol#: 1
M 1 HFD-7 Vol#: 1
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods
C 12615 Ann Dillenutin Vol#: 783
C 12616 Eleanor Wilson Vol#: 783
C 12617 Donald DeBona Vol#: 783
C 12618 Jeremy Marks Vol#: 783
C 12619 L Bangent Vol#: 783
C 12620 Shellie Willet Vol#: 783
EMC 5229 Andy Metrick Vol#: 783
EMC 5230 Andy Metrick Vol#: 783
EMC 5231 Edward Triska Vol#: 783
EMC 5232 Holly Owens Vol#: 783
00V-0610 Infrared Laser Aiming Light
LET 1 HFZ-300 to Insight Technology Inc. Vol#: 1
01E-0366 Patent Term Extension Application, PEG-Intron No. 5,951,974
LET 3 U.S. Patent & Trademark Office Vol#: 1
M 2 HFD-7 Vol#: 1
01E-0404 Patent Term Extension Application; No. 5,444,106
LET 3 U.S. Patent & Trademark Office Vol#: 1
M 2 HFD-7 Vol#: 1
01P-0320 Establish Format Standards for Ingredient Labels on Food Pro
C 161 Sita Halperin Vol#: 6
C 162 Sheila Peskin Vol#: 6
C 163 Roy, Lyn & Russell Johnson Vol#: 6
C 164 Victoria A. Karabinus Vol#: 6
C 165 Ms. Dolores A. La Piana Vol#: 6
C 166 Diane Mowry Vol#: 6
C 167 James S. Gilliland Vol#: 6
C 168 Charles R. Vocke Vol#: 6
C 169 Ann Barkley Macalusoo Vol#: 6
C 170 Mrs. L. Delloff Vol#: 6
C 171 Jane Wilson Vol#: 6
C 172 Allan & RuthAnn Boersma Vol#: 6
C 173 Mr. & Mrs. George Herman Vol#: 6
C 174 Lubov Mandel Vol#: 6
C 175 Catherine Modre Vol#: 6
C 176 Sheere Tucker Vol#: 6
C 177 Joanne Hedges Vol#: 6
C 178 Form Letter count 55 Vol#: 9
01P-0323 Not rely on non-public filings to approve an innovator NDA;
LET 2 Pfizer Inc. & Pharmacia Corp. Vol#: 1
02D-0094 IND exemptions studies lawfully marketed Cancer drug biologi
GDL 1 GUIDANCE Vol#: 1
NAD 1 Vol#: 1
02D-0096 Nucleic acid tests samples donors whole blood component HIV1
GDL 1 GUIDANCE Vol#: 1
NAD 1 Vol#: 1
02E-0019 Patent Term Application for Axert No. 5,565,447
LET 3 U.S. Patent & Trademark Office Vol#: 1
M 2 HFD-7 Vol#: 1
02E-0023 Patent Term Application for Definity No. 5,527,521
LET 3 U.S. Patent & Trademark Office Vol#: 1
M 2 HFD-7 Vol#: 1
02N-0037 Public Informational meeting on Antimicrobial Resistance
NM 1 Vol#: 1
02N-0054 Labeling Requirements for Color Additives
NCR 1 Vol#: 1
02N-0063 Consumer Surveys on Food & Dietary Supplement Labeling
EMC 7 Jarrows Formulas, Inc. Vol#: 1
EMC 8 American Herbal Prods. Assn. Vol#: 1
02N-0101 Amfepramone(diethylpropion) Amineptine; Burprenorphine
N 1 Vol#: 1
02V-0146 Laser Light Show
ACK 1 HFA-305 Vol#: 1
VAR 1 Electro Magic Vol#: 1