DOCKETS ENTERED on 09/04/01

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 September 4, 2001

TABLE OF CONTENTS

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78N-0224 TRIMETHOBENZAMIDE HYDROCHLORIDE SUPPOSITORIES *
97N-0497 Allogeneic Peripheral and Placental/ Umbilical Cord Blood *
00D-1598 Voluntary Labeling for Bioengineered Foods *
01D-0193 Premarket Notifications for Biological Indicators Intended *
01D-0232 Reprocessing/Reuse of Single-Use Devices for Industry/FDA *
01N-0103 180 day Genetic Exclusivity Intersection - Pediatric *
01P-0346 Modify 8/14/01 deadline re: submission & approval of PMA *
01P-0382 ANADA suitability which differs in dosage form from innovato *
01P-0383 Determine whether Imuran tablets has been withdrawn for safe *
01P-0385 ANADA Suitability for Oxytetracycline 300 mg/mL Injection *

77N-0085 Saccharin and Its Salts

CA 3370 Barbara Z. Powell Vol#: 279

78N-0224 TRIMETHOBENZAMIDE HYDROCHLORIDE SUPPOSITORIES

LET 2 HFD-7 to King Pharmaceuticals Inc Vol#: 1

LET 3 King Pharmaceuticals Inc Vol#: 1

LET 4 HFD-7 to King Pharmaceuticals Inc Vol#: 1

78N-0227 Trimethobenzamide Hydrochloride Injection & Capsules

LET 2 HFD-7 to King Pharmaceuticals Inc Vol#: 1

LET 3 King Pharmaceuticals Inc Vol#: 1

LET 4 HFD-7 to King Pharmaceuticals Inc Vol#: 1

97N-0497 Allogeneic Peripheral and Placental/ Umbilical Cord Blood

C 14 New York Blood Center Vol#: 5

00D-1598 Voluntary Labeling for Bioengineered Foods

C 9298 Irene Ryke Vol#: 464

C 9299 Nancy Watson Dean Vol#: 464

C 9300 Marilynn Jacobs Vol#: 464

C 9301 Shirley Geiser Vol#: 464

C 9302 Helen Larsen Vol#: 464

C 9303 Terrie Balho Vol#: 464

C 9304 E. Kapoor Vol#: 464

C 9305 Julia Cato Vol#: 464

C 9306 Angela Junk Vol#: 464

C 9307 Edith E. Katz Vol#: 464

C 9308 Brian Beffort Vol#: 464

C 9309 Mrs DE Hirschfelder Vol#: 464

C 9310 Sharon Petrosky et al Vol#: 464

C 9311 Beth A. Baron Vol#: 464

C 9312 Judith A. Cook Vol#: 464

C 9313 Julie C. Jacobs Vol#: 464

C 9314 Philip Reseigh Vol#: 464

C 9315 Tabitha M. Ziober Vol#: 464

C 9316 D.W. Borland Vol#: 464

C 9317 Richard Newell, Jr. Vol#: 464

C 9318 Geoffrey Robert Golub Vol#: 464

C 9319 Herman F. Blumel, Jr. Vol#: 464

C 9320 K. Bowen Vol#: 464

C 9321 Amy Buringrud Vol#: 465

C 9322 Beth Kandoll Vol#: 465

C 9323 Marlys Cleveland Vol#: 465

C 9324 Robert O'Brien Vol#: 465

C 9325 Sharon L. Sprong et al Vol#: 465

C 9326 Paul Stallings Vol#: 465

C 9327 Jamie Corcoran Vol#: 465

C 9328 Samuel Du Vol#: 465

C 9329 Barbara Carmel Vol#: 465

C 9330 Jean McKay Vol#: 465

C 9331 Virginia Schulman Vol#: 465

C 9332 Ronald & Donna Raven Vol#: 465

C 9333 Cat Cook Vol#: 465

C 9334 Gloria A. Estrada Vol#: 465

C 9335 Patricia Samul Vol#: 465

C 9336 George Zuk Vol#: 465

C 9337 Richard C. Finch Vol#: 465

C 9338 Sheila Heckman Vol#: 465

C 9339 Larry O. Noggle Vol#: 465

C 9340 Chris Mann Vol#: 465

C 9341 Carol E. Benik Vol#: 465

C 9342 Willard Cottrell Vol#: 465

C 9343 Marilynn Jacobs Vol#: 465

C 9344 Kathy Labriola Vol#: 465

C 9345 Rae E. Robinson Vol#: 465

C 9346 Barbara Buckley Vol#: 465

C 9347 No signature Vol#: 465

C 9348 Ramona Haucock Vol#: 465

C 9349 JoAnn Hanson Vol#: 465

C 9350 Irene Ramirez Vol#: 465

C 9351 Gary Bolton, R.Ph., CCN Vol#: 465

C 9352 Sherri Forehand Vol#: 465

C 9353 Don Wilson Vol#: 465

C 9354 Mark Clifton Vol#: 465

C 9355 Lillian Tossman Vol#: 465

C 9356 David Michaels Vol#: 465

C 9357 Ken H. Miller Vol#: 465

C 9358 Loraine E. Tisdale Vol#: 465

C 9359 Uel Wade Vol#: 465

C 9360 T. Barone Vol#: 465

C 9361 Emily Schilling Vol#: 465

C 9362 Jere Bouden Vol#: 465

C 9363 Martha T. Gwyn Vol#: 465

C 9364 Lisa Marie Beverly Vol#: 465

C 9365 Kari Carlin Aist Vol#: 465

C 9366 Valerie Plaschka Vol#: 465

C 9367 Joslien Gilchrist Vol#: 465

C 9368 Andrew L. Donaldson Vol#: 465

C 9369 Rawena G. Elswick Vol#: 465

C 9370 Dorothy Kennedy Vol#: 465

C 9371 Mildred Rankin Vol#: 465

C 9372 Paula Senft Vol#: 465

C 9373 Eleanor J. Gaul Vol#: 465

C 9374 Genevieve Hayes Vol#: 465

C 9375 Jeanette Muzima Vol#: 465

C 9376 Dennis Smock Vol#: 465

C 9377 Anne Ferrer Vol#: 465

C 9378 Trudy Roddick Vol#: 465

C 9379 Joshua Fett Vol#: 465

C 9380 Murray Passarieu Vol#: 465

C 9381 Mary Brown Vol#: 465

C 9382 Rose Strick Vol#: 465

C 9383 Paul Rodriguez Vol#: 465

C 9384 Jean Baumber Vol#: 465

C 9385 Drew A. Martin Vol#: 465

C 9386 M Quick, Jacob & Cheryl Vol#: 465

C 9387 G.A. Morningstar Vol#: 465

C 9388 Lee Javed Vol#: 465

C 9389 Mercedes Brugh Vol#: 465

C 9390 Paul M. Lappen Vol#: 465

C 9391 Elizabeth Testino Vol#: 465

C 9392 Dawn Mallow Vol#: 465

C 9393 LaVerne E. Domach Vol#: 465

C 9394 Gail Woods Vol#: 465

C 9395 Dorothy Hickson Vol#: 465

C 9396 Angela Hampton Vol#: 465

C 9397 Wilma Bauer Vol#: 465

C 9398 Eligible Vol#: 465

C 9399 Sheila Dupee Vol#: 465

C 9400 Sheila Finch Manzagol Vol#: 465

C 9401 Elizabeth M. Eckat Vol#: 465

C 9402 Donna Jean Blaney Vol#: 465

C 9403 Mrs. John T. Glynn Vol#: 465

C 9404 Ariene A. Harrison Vol#: 465

C 9405 John Saemann Vol#: 465

EC 323 U.S. Citizen Vol#: 93

01D-0193 Premarket Notifications for Biological Indicators Intended

C 10 3M Health Care Vol#: 1

01D-0232 Reprocessing/Reuse of Single-Use Devices for Industry/FDA

C 2 Assn. of Disposable Device Manufacturers Vol#: 1

01N-0103 180 day Genetic Exclusivity Intersection - Pediatric

C 7 AZ House of Representatives Vol#: 1

01P-0346 Modify 8/14/01 deadline re: submission & approval of PMA

LET 1 HFZ-1 to Vanguard Medical Concepts Inc Vol#: 1

LET 2 HFZ-1 to Alliance Medical Corporation Vol#: 1

LET 3 HFZ-1 to Medical Instruments Technology Vol#: 1

PAV 1 HFZ-1 to SterilMed, Inc. Vol#: 1

01P-0382 ANADA suitability which differs in dosage form from innovato

ACK 1 HFA-305 Vol#: 1

CP 1 ECO LLC Vol#: 1

01P-0383 Determine whether Imuran tablets has been withdrawn for safe

ACK 1 HFA-305 Vol#: 1

CP 1 AAI International an aai Pharma Co. Vol#: 1

01P-0385 ANADA Suitability for Oxytetracycline 300 mg/mL Injection

ACK 1 HFA-305 Vol#: 1

CP 1 Cross Vetpharm Group Ltd. Vol#: 1

01V-0386 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Creative Sound and Lighting Systems Vol#: 1

01V-0387

ACK 1 HFA-305 Vol#: 1

VAR 1 Sound & Lighting Systems Vol#: 1

01V-0388

ACK 1 HFA-305 Vol#: 1

VAR 1 Flying Colors Concert Lighting Vol#: 1