Food and Drug Administration

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]

DOCKETS ENTERED on November 26, 1999

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

[FDA DOCKETS PAGE][FDA HOME PAGE]

97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection) *
98D-0388 Dermatological Drug Product NDA's and ANDA's *
98D-0994 Draft Guidance for Industry on BACPAC I *
98N-0313 Surgeons's and Patient Examination Gloves Reclassification *
98P-0680 Amend reg re: sale & distribution of turtles & viable eggs *
99D-0529 Draft Guidance for Ind - Changes to an Approved NDA or ANDA *
99D-1651 Chemistry,Mfging/Control Chges to an approved NADA/ANADA *
99M-4693 PMA Staarvisc Sodium Hyaluronate, P960033 *
99M-4776 PMA Surgifoam Absorbable Gelatin Spongel, P990004 *
99N-0193 Supplements and Other Changes to an Approved Application *
99V-5110 Mobolazer ML10-200, ML10-300, ML300W, ML10 ML10-1.0G *

97N-0074 President's National Food Safety Initiative

C 175 Form Letter count 6 Vol#: 13

C 176 Helene Lieto Vol#: 12

C 177 Gail Spies Vol#: 12

C 178 Judy Cammer Vol#: 12

C 179 Gary T. Nagasawa Vol#: 12

C 180 J. Muha Vol#: 12

C 181 Jon Gerault-Jones Vol#: 12

C 182 Matthew Judd McGuire Vol#: 12

C 183 Carol RS Treacy Vol#: 12

C 184 Mark Goldberg Vol#: 12

C 185 Janet L. Parrish Vol#: 12

C 186 Alice Piel Vol#: 12

C 187 Anita Sax Vol#: 12

C 188 James M. Shea Vol#: 12

C 189 Richard Laybourn Vol#: 12

C 190 Susan Lyons Vol#: 12

C 191 Karen Thomas Vol#: 12

C 192 Evelyn Phillips-Gutchell Vol#: 12

97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection)

LET 298 HFS-456 to Maxi-Health Herb Products Inc Vol#: 7

LET 299 HFS-456 to ShmsHrs. inc Vol#: 7

LET 300 HFS-456 to E'OLA International Vol#: 7

LET 301 HFS-456 to Weider Nutrition Internationa Vol#: 7

LET 302 HFS-456 to E'OLA International Vol#: 7

LET 303 HFS-456 to Herbalife International of Am Vol#: 7

LET 304 HFS-456 to American Speciality Health & Vol#: 7

LET 305 HFS-456 to Herbs Etc., Inc. Vol#: 7

LET 306 HFS-456 to Melaleuca Inc Vol#: 7

LET 307 HFS-456 to Meditalent Enterprises Ltd Vol#: 7

LET 308 HFS-456 to FoodScience Corporation Vol#: 7

LET 309 HFS-456 to Health from the Sun Vol#: 7

LET 310 HFS-456 to Cell Tech Vol#: 7

LET 311 HFS-456 Boston University School of Medi Vol#: 7

LET 312 HFS-456 to Hershey Foods Corporation Vol#: 8

LET 313 HFS-456 to Nordic Naturals Vol#: 8

LET 314 HFS-456 to Atkins Nutritionals Inc Vol#: 8

LET 315 HFS-456 to Nutritional Specialties Inc Vol#: 8

LET 316 HFS-456 to Herbalogix Inc Vol#: 8

98D-0388 Dermatological Drug Product NDA's and ANDA's

ACK 2 HFA-305 Vol#: 2

CP 2 Ortho Dermatological, a div of Ortho-McN Vol#: 2

98D-0994 Draft Guidance for Industry on BACPAC I

C 39 Active Pharmaceutical Ingredients Commit Vol#: 2

98N-0313 Surgeons's and Patient Examination Gloves Reclassification

C 39 MedChi Vol#: 8

C 40 APIC Vol#: 8

98P-0680 Amend reg re: sale & distribution of turtles & viable eggs

ELET1 Richard John Fife Vol#: 1

99D-0529 Draft Guidance for Ind - Changes to an Approved NDA or ANDA

C 41 Active Pharmaceutical Ingredients Commit Vol#: 3

99D-1651 Chemistry,Mfging/Control Changes to an approved NADA/ANADA

C 1 Active Pharmaceutical Ingredients Commit Vol#: 1

99E-5112 Patent Extension Novoseven, #4,784,950

APP 1 ZymoGenetics Inc Vol#: 1