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DOCKETS ENTERED on November 15, 2000

TABLE OF CONTENTS

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78N-036L OTC Laxative *
94S-0120 510K Substantially Equivalent List *
97N-0436 Methods informing consumers of contents of bottle water *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
99F-2673 Irradiation in the Production, Processing & Handling of Food *
00D-1424 Analytical procedures and methods validation; drug substance *
00N-1379 Safe processing/importing of fish & fishery products *
00P-1499 Remove alosetron (Lotronex) from the market *
00P-1621 ANDA suitability for cladribine-lipomed 10 mg/5ml *
00P-1623 WDL of letter issued regarding product Misoprostol *
78N-036L OTC Laxative

C 205 C B Fleet Company Inc Vol#: 117

93F-0319 Safe use of acrylonitrile-butadiene copolymer hydrogenated

BKG 1 Background material Vol#: 2

EA 1 Environmental Assessment Vol#: 2

FONS1 Finding of no significant Vol#: 2

NFR 1 HFS-215 Vol#: 2

94S-0120 510K Substantially Equivalent List

LST 100 October 2000 510k Monthly Vol#: 23

97D-0530 Use of IEC 60601 Standards; Medical Electrical;

N 1 HFZ-100 Vol#: 1

97N-0436 Methods informing consumers of contents of bottle water

C 224 S Davis Vol#: 7

EMC 65 L Johnson Vol#: 7

EMC 66 D McKay Vol#: 7

EMC 67 K Smith Vol#: 7

EMC 68 A Deane Vol#: 7

EMC 69 S Prince Vol#: 7

98N-0182 Bulk Drug Substances To Be Used in Pharmacy Compounding

C 174 Bioenergy Inc Vol#: 22

98P-0151 Introduction Of Downed Cattle Into The Food Supply

C 2692 L Nakata Vol#: 81

C 2693 J Turnbull Vol#: 81

C 2694 J Graves Vol#: 81

C 2695 S Romano Vol#: 81

C 2696 N Scheuermann Vol#: 81

C 2697 A Vozar Vol#: 81

C 2698 J McCarthy Vol#: 81

C 2699 N Capian Vol#: 81

C 2700 B Blitz Vol#: 81

C 2701 K Bosi Vol#: 81

EMC 276 E Sher Vol#: 81

EMC 277 C de la Garza Vol#: 81

EMC 278 J Mitchell Vol#: 81

EMC 279 L Nicholas Vol#: 81

EMC 280 S Lakies Vol#: 81

EMC 281 J Novak Vol#: 81

EMC 282 Betina Francis Vol#: 81

EMC 283 V Housley Vol#: 81

EMC 284 C Benedict Vol#: 81

EMC 285 M Hsu Vol#: 81

EMC 286 L Reib Vol#: 81

EMC 287 S Wrathall Vol#: 81

EMC 288 M Adams Vol#: 81

EMC 289 K Stevens Vol#:

EMC 290 S Howard Vol#: 81

EMC 291 G Welch Vol#: 81

EMC 292 Welch Family & Genta Family Vol#: 81

EMC 293 J Stiles Vol#: 81

EMC 294 J Sultz Vol#: 81

EMC 295 W Barrett Vol#: 81

EMC 296 P Crowson Vol#: 81

EMC 297 K Fleming Vol#: 81

EMC 298 C Chesebrough Vol#: 81

EMC 299 C Mott Vol#: 81

EMC 300 J Lupton Vol#: 81

EMC 301 C Blevins Vol#: 81

EMC 302 T Clever Vol#: 81

EMC 303 L Fairchild Vol#: 81

EMC 304 M Lucas Vol#: 81

EMC 305 R Whitman Vol#: 81

EMC 306 Y Catron Vol#: 81

EMC 307 J Dekker Vol#: 81

EMC 308 L Coffman Vol#: 81

EMC 309 L Schiro Vol#: 81

99F-2673 Irradiation in the Production, Processing & Handling of Food

EMC 1 J Hadcroft Vol#: 1

EMC 2 K Hinkley Vol#: 1

EMC 3 P Moss Vol#: 1

EMC 4 Z Lewis Vol#: 1

EMC 5 A Kovaric Vol#: 1

EMC 6 J Salans Vol#: 1

EMC 7 P Coe Vol#: 1

EMC 8 V Moore Vol#: 1

EMC 9 P Moss Vol#: 1

EMC 10 S Dirck Vol#: 1

EMC 11 deedub Vol#: 1

EMC 12 C Bain Vol#: 1

EMC 13 D Pantle Vol#: 1

EMC 14 J Konhaus Vol#: 1

EMC 15 D Pantle Vol#: 1

EMC 16 Carol Vol#: 1

EMC 17 K Dorn Vol#: 1

EMC 18 T Holland Vol#: 1

EMC 19 M Garrity Vol#: 1

EMC 20 J Emmert Vol#: 1

EMC 21 E Mauro Vol#: 1

EMC 22 C Wilkes Vol#: 1

EMC 23 M Sinclair Vol#: 1

EMC 24 A Slesiter Vol#: 1

EMC 25 Barbara Crawford Vol#: 1

99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings

C 16244 G Grenier Vol#: 477

C 16245 R Fehr Vol#: 477

C 16246 J Christure Vol#: 477

C 16247 P Blair Vol#: 477

C 16248 N Clark Vol#: 477

C 16249 C Johnson Vol#: 477

C 16250 V Osborne Vol#: 477

C 16251 S. Darna Vol#: 477

C 16252 D Leitroy Vol#: 477

C 16253 J Gallagher Vol#: 477

C 16254 L Stengel Vol#: 477

C 16255 Concerned Parent Vol#: 477

C 16256 N Sullivan Vol#: 477

C 16257 R Powers Vol#: 477

C 16258 R Dunfee Vol#: 477

C 16259 B Colson Vol#: 477

C 16260 J Falkenbury Vol#: 477

C 16261 J Morgan Vol#: 477

C 16262 E Morehead Vol#: 477

C 16263 C Jackson Vol#: 477

C 16264 A Lennon Vol#: 477

C 16265 R Henderson Vol#: 477

C 16266 A Woodward Vol#: 477

C 16267 G Willing Vol#: 477

C 16268 T Bates Vol#: 477

C 16269 T Tanzi Vol#: 477

C 16270 L Borchard Vol#: 477

C 16271 L Larson Vol#: 477

C 16272 C Siedelmann Vol#: 477

C 16273 J Lane Vol#: 477

C 16274 M Dillon Vol#: 477

C 16275 D White Vol#: 477

C 16276 G Spears Vol#: 477

C 16277 R Schriber Vol#: 477

EMC 3291 S Ross Vol#: 477

EMC 3292 D Chandler Vol#: 477

EMC 3293 A Vierra Vol#: 477

EMC 3294 M Polidori Vol#: 477

EMC 3295 A Breseke Vol#: 477

EMC 3296 G Howard Vol#: 477

EMC 3297 I Swenson Vol#: 477

00D-1424 Analytical procedures and methods validation; drug substance

C 2 Purdue Pharma LP Vol#: 1

00M-1615 P980010 - DTU-one Ultrasound Scanner

AAV 1 Osteometer MediTech, Inc. Vol#: 1

00M-1616 N18286/S012 - Gelfoam Sterile Powder

AAV 1 Pharmacia & Upjohn Company Vol#: 1

00N-1379 Safe processing/importing of fish & fishery products

EMC 1 C Christin Vol#: 1

00P-1499 Remove alosetron (Lotronex) from the market

C 9 G Guillory Vol#: 1

C 10 Gastroenterology Group PA Vol#: 1

EMC 7 J Goff Vol#: 1

EMC 8 D Mulock Vol#: 1

EMC 9 C Cattano Vol#: 1

EMC 10 T Schubert Vol#: 1

EMC 11 R Forsyth Vol#: 1

EMC 12 C Burke Vol#: 1

EMC 13 P Raymond Vol#: 1

00P-1621 ANDA suitability for cladribine-lipomed 10 mg/5ml

ACK 1 HFA-305 Vol#: 1

CP 1 Lipomed, Inc. Vol#: 1

00P-1623 WDL of letter issued regarding product Misoprostol

ACK 1 HFA-305 Vol#: 1

CP 1 American College of OB-GYN (ACOG) Vol#: 1

00V-1553 Laser light show

VRA 1 HFZ-340 to Metropolis Theater Vol#: 1

00V-1573 Laser Display Device

VRA 1 HFZ-340 to Deja Vu of Washington Park Vol#: 1

00V-1576 AN/PEQ-2A, Target Pointer-Illuminator/Aiming Light

VRA 1 HFZ-340 to Insight Technology Inc. Vol#: 1

00V-1622 Laser light show

ACK 1 HFA-305 Vol#: 1

VAR 1 Opryland Hospitality & Attractions/Opryl Vol#: 1

00V-1624 Laser light show

ACK 1 HFA-305 Vol#: 1

VAR 1 The Club at II Panino Vol#: 1