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Dockets Entered On June 20, 2003
TABLE OF
CONTENTS (Linked) |
|
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Docket #
|
|
Title |
|
|
|
|
1976N-0052G |
|
OTC general comments & combinations
|
|
|
|
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1993P-0174
|
|
Amend
Regs for Liquid Medicated Animal Feed |
|
|
|
|
1996N-0417
|
|
CGMP
in Mfg. Packing or Holding Dietary Supplements
|
|
|
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1998D-0785
|
|
Medical imaging drugs and biologics
|
|
|
|
|
2000N-1484
|
|
Safety Reporting Requirements Human Drug/Biological
Products |
|
|
|
|
2000N-1571
|
|
Enrofloxacin for Poultry: Opportunity for
Hearing |
|
|
|
|
2002N-0204
|
|
Bar
Code Label Requirements for human drug products
|
|
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|
2002N-0475
|
|
Financial Relationships & Interest
in Research Involving Hum |
|
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|
2002P-0256
|
|
Determine
if ANDA 76-122 is Entitled to 180 Days Exclusivity
|
|
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2002P-0391
|
|
Determine Whether Alphagan has been Voluntarily
Withdrawn |
|
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|
|
2002P-0404
|
|
Determination re: Withdraw of ALPHAGAN
|
|
|
|
|
2003D-0062
|
|
Medical Devices; Assessing User Fees: PMA
Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement
Definitions, Bundling Multiple Devices in a Single Application,
and Fees for Combination |
|
|
|
|
2003D-0186
|
|
Guidance for Industry: Use of Material From
Deer and Elk In Animal Feed |
|
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|
2003N-0169
|
|
Dental Amalgam; Request for Information
|
|
|
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|
2003P-0067
|
|
Amend
CFR to include provision to establish prescription sun
|
|
|
|
|
2003P-0113
|
|
Levoxyl (levothyroxine sodium) tablets
(NDA #21-301) |
|
|
|
|
2003P-0288
|
|
Health
Center, be deemed a " pharmacy of an other health care entity"
|
|
|
| CONTENTS |
|
|
|
1976N-0052G
|
|
OTC
general comments & combinations |
|
|
|
LET 120 |
|
Lil Drug Store Products |
|
Vol #: |
|
35 |
|
|
|
1990P-0181
|
|
ANADA
Suitability for Combo Prod.of Chlortetracycline + Sulf |
|
|
|
ACK 1 |
|
HFA-305 to American Cyanamid Co. |
|
Vol #: |
|
1 |
|
|
|
1993P-0174
|
|
Amend
Regs for Liquid Medicated Animal Feed |
|
|
|
EXT 1 |
|
American Feed Industry Assn (AFIA) |
|
Vol #: |
|
1 |
|
|
|
1995N-0304 |
|
|
|
|
C 4040 |
|
Patricia Weyland,MS,APRN,BC,FNP |
|
Vol #: |
|
374 |
|
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|
|
C 4041 |
|
David Grossman |
|
Vol #: |
|
374 |
|
|
|
|
1996N-0417 |
|
CGMP
in Mfg. Packing or Holding Dietary Supplements
|
|
|
|
|
C 122 |
|
National Vitamin Company, Inc. |
|
Vol #: |
|
17 |
|
|
|
|
1998D-0785 |
|
Medical
imaging drugs and biologics
|
|
|
|
|
C 23 |
|
POINT Biomedical |
|
Vol #: |
|
5 |
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|
C 24 |
|
PETNET Pharmaceuticals, Inc. (PETNET) |
|
Vol #: |
|
5 |
|
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|
C 25 |
|
Council on Radionuclides and Radiopharmaceuticals
(CORAR) |
|
Vol #: |
|
5 |
|
|
|
|
C 26 |
|
Jefferson Medical College |
|
Vol #: |
|
5 |
|
|
|
|
1998P-0151 |
|
Introduction Of Downed Cattle Into The Food Supply
|
|
|
|
|
EMC 3210 |
|
Carolyn Cryran |
|
Vol #: |
|
281 |
|
|
|
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|
EMC 3211 |
|
Glenda Bailey |
|
Vol #: |
|
281 |
|
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|
EMC 3212 |
|
Gail Johnson |
|
Vol #: |
|
281 |
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|
EMC 3213 |
|
Eleanor Brennan |
|
Vol #: |
|
281 |
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|
EMC 3214 |
|
Chris Braun-Gelhaar |
|
Vol #: |
|
281 |
|
|
|
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|
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|
EMC 3215 |
|
Dax Riner |
|
Vol #: |
|
281 |
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EMC 3216 |
|
Sonja Stalnaker |
|
Vol #: |
|
281 |
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|
EMC 3217 |
|
Patricia Miko |
|
Vol #: |
|
281 |
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|
EMC 3218 |
|
Cristina Ventry |
|
Vol #: |
|
281 |
|
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|
EMC 3219 |
|
Pamela Rowe |
|
Vol #: |
|
281 |
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|
EMC 3220 |
|
Sharon Intilli |
|
Vol #: |
|
281 |
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|
|
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|
EMC 3221 |
|
Jodi Bell |
|
Vol #: |
|
281 |
|
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|
EMC 3222 |
|
Denise Garcia |
|
Vol #: |
|
281 |
|
|
|
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|
EMC 3223 |
|
Janet Auer |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3224 |
|
Diana Zelnio |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3225 |
|
cmcindoe |
|
Vol #: |
|
281 |
|
|
|
|
|
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|
EMC 3226 |
|
Kim Miller |
|
Vol #: |
|
281 |
|
|
|
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|
EMC 3227 |
|
Harley J. Shelley |
|
Vol #: |
|
281 |
|
|
|
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|
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|
EMC 3228 |
|
Gadebuck |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3229 |
|
Hope Sternberg |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3230 |
|
Sue Katz |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3231 |
|
Debbie Slack |
|
Vol #: |
|
281 |
|
|
|
|
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|
EMC 3232 |
|
Linda |
|
Vol #: |
|
281 |
|
|
|
|
EMC 3233 |
|
Jennifer Danner |
|
Vol #: |
|
281 |
|
|
|
|
|
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|
EMC 3234 |
|
EBrock |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3235 |
|
Christina Tauber |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3236 |
|
Nicole Polley |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3237 |
|
Laurie Loveman |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3238 |
|
Nancy L. Haynes |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3239 |
|
Margaret W. Pierson, RHIA |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3240 |
|
Megan Hanna |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3241 |
|
Terree Flowers |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3242 |
|
Sharon A. Balzano |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3243 |
|
Alice Bartholomew |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3244 |
|
Linda Mann |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3245 |
|
Yelina Catron |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3246 |
|
Pamela Penny |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3247 |
|
Colette Tunney |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3248 |
|
Dr. Gretchen Rolfe |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3249 |
|
Heidi Gothard |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3250 |
|
Cindy D'Andrea |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3251 |
|
Karen Ziomek Vayda |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3252 |
|
Kay Buhler |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3253 |
|
Pat Kelly |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3254 |
|
Maxine Mlodzik |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3255 |
|
Terri Cordrey |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3256 |
|
Laura F. James |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3257 |
|
Susan D. Baker |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3258 |
|
Todd Wilson |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3259 |
|
Suzanne Talhouk |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3260 |
|
Kim Marsala |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3261 |
|
Nancy A. Kosa |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3262 |
|
Noreen Byatt |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3263 |
|
Christine Casivant |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3264 |
|
Marjorie Olsen |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3265 |
|
Louise Barton |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3266 |
|
Kim McRoberts-Wilson BS, CVT |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3267 |
|
Peter Gioimo |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3268 |
|
Melinda Hanson |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3269 |
|
Suzie Quaid |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EMC 3270 |
|
Valerie A. Lang |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3271 |
|
Beth Nielsen-Suarez |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3272 |
|
Joviann Mech |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3273 |
|
Melissa Ochal |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3274 |
|
Meri Chokrevski |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3275 |
|
Maria Farina |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3276 |
|
Linda A. Bunch |
|
Vol #: |
|
281 |
|
|
|
|
|
|
|
EMC 3277 |
|
Carly Noble |
|
Vol #: |
|
281 |
|
|
|
|
2000N-1484 |
|
Safety
Reporting Requirements Human Drug/Biological Products |
|
|
|
|
C 2 |
|
Delta Blood Bank |
|
Vol #: |
|
3 |
|
|
|
|
2000N-1571 |
|
Enrofloxacin
for Poultry: Opportunity for Hearing
|
|
|
|
|
LET 15 |
|
Bayer Corporation |
|
Vol #: |
|
378 |
|
|
|
|
|
|
|
2001P-0230 |
|
Domestic Marketing & Importation of Transgenic
Fish |
|
|
|
|
EMC 2732 |
|
Ginny Longtin |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2733 |
|
Maureen Langberg |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2734 |
|
Eva W. Ahring |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2735 |
|
Tracey L. Ahring |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2736 |
|
Kathi Kruse |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2737 |
|
Jill Cooper |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2738 |
|
Eva Lewis |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2739 |
|
Anton Vojacek |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2740 |
|
Conrad Miller, M.D. |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2741 |
|
John R. Anderson |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2742 |
|
Nancy Berman |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2743 |
|
Larissa Lockwood |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2744 |
|
Kelly Winterton |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2745 |
|
Erin Conroy |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2746 |
|
Carol Greenstein |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2747 |
|
Peter Roth |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2748 |
|
Claire Lewis-Jones |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2749 |
|
Mitchell Solovay, RN |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2750 |
|
Kyle Robert Chapman |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2751 |
|
Taran Singleton |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2752 |
|
James Wagner |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EMC 2753 |
|
Lisa Bromfield |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2754 |
|
Lynne Benson |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2755 |
|
Mrs. Beth Helm |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2756 |
|
Jennifer Notman |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2757 |
|
Betty F. Dean |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2758 |
|
Bruce Huron |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2759 |
|
Arleen S. Wiley |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2760 |
|
B. McClintock |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2761 |
|
Deidre Purcell |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2762 |
|
Pepi Shell |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2763 |
|
Alice Neff |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2764 |
|
Janis Price |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2765 |
|
Greg Williams |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2766 |
|
Rosalie Hewitt |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2767 |
|
Gregg Mau |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2768 |
|
Morris B. Miller |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2769 |
|
Mary White |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2770 |
|
James L. Moore |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2771 |
|
April Walker |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2772 |
|
Jenny Moore |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2773 |
|
Mike & Deana McCauley |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2774 |
|
David Vaughan |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2775 |
|
April Ambrose |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2776 |
|
Teresa Good |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2777 |
|
C. Finlayson |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2778 |
|
Marcus Humus |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2779 |
|
Peter Blied |
|
Vol #: |
|
228 |
|
|
|
|
|
|
|
EMC 2780 |
|
Yasmin Myers |
|
Vol #: |
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228 |
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EMC 2781 |
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Karie L. Knoke |
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Vol #: |
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228 |
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EMC 2782 |
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George Weissmann, Ph.D. |
|
Vol #: |
|
228 |
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EMC 2783 |
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Barbara Birnbaum |
|
Vol #: |
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228 |
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EMC 2784 |
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Martha Castillo |
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Vol #: |
|
228 |
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EMC 2785 |
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Dona Heiner |
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Vol #: |
|
228 |
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EMC 2786 |
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Lisa White |
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Vol #: |
|
228 |
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EMC 2787 |
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Carol E. Meyer |
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Vol #: |
|
228 |
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EMC 2788 |
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Leland Merk |
|
Vol #: |
|
228 |
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EMC 2789 |
|
Sheryl Arndt |
|
Vol #: |
|
228 |
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EMC 2790 |
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Georgene Nigbor |
|
Vol #: |
|
228 |
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EMC 2791 |
|
Don & Shirlain Kramlich |
|
Vol #: |
|
228 |
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EMC 2792 |
|
number not used |
|
Vol #: |
|
228 |
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EMC 2793 |
|
Susan Gerritsen |
|
Vol #: |
|
228 |
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EMC 2794 |
|
G. Konecky |
|
Vol #: |
|
228 |
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2002N-0204 |
|
Bar
Code Label Requirements for human drug products
|
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C 112 |
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National Hemophilia Foundation |
|
Vol #: |
|
15 |
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C 113 |
|
Tri-TAC |
|
Vol #: |
|
15 |
|
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2002N-0275 |
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Bioterrorism Preparedness; Administrative Detention
|
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C 23 |
|
Pushya Potnis |
|
Vol #: |
|
3 |
|
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2002N-0475 |
|
Financial
Relationships & Interest in Research Involving Hum |
|
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|
C 32 |
|
University of California |
|
Vol #: |
|
2 |
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C 33 |
|
University of Kentucky |
|
Vol #: |
|
2 |
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2002P-0256 |
|
Determine
if ANDA 76-122 is Entitled to 180 Days Exclusivity
|
|
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|
WDL 1 |
|
Mylan Pharmaceuticals, Inc. |
|
Vol #: |
|
1 |
|
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2002P-0391 |
|
Determine
Whether Alphagan has been Voluntarily Withdrawn |
|
|
|
LET 2 |
|
HFD-7 to IVAX Pharmaceuticals, Inc. |
|
Vol #: |
|
1 |
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2002P-0404 |
|
Determination
re: Withdraw of ALPHAGAN
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|
LET 2 |
|
HFD-7 to Alcon, Inc. |
|
Vol #: |
|
1 |
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2003D-0061 |
|
Comparability Protocols Chemistry Manufacturing
and controls |
|
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EC 3 |
|
Farag, Samir |
|
Vol #: |
|
1 |
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2003D-0062 |
|
Medical
Devices; Assessing User Fees: PMA Supplement Definitions, Modular
PMA Fees, BLA and Efficacy Supplement
Definitions, Bundling Multiple Devices in a Single Application,
and Fees for Combination |
|
|
|
C 1 |
|
Olympus America, Inc. |
|
Vol #: |
|
1 |
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2003D-0118 |
|
Decorative Contact Lens (Import alert #86-10)
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|
C 2 |
|
Fred R. Shanks, MD |
|
Vol #: |
|
1 |
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C 3 |
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Charles F. Cohen, O.D. |
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Vol #: |
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1 |
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C 4 |
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Stewart E. Galeucia, O.D. |
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Vol #: |
|
1 |
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C 5 |
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Claudia Gonzalez, O.D. |
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Vol #: |
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1 |
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C 6 |
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E.D. Attaya, O.D. |
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Vol #: |
|
1 |
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C 7 |
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J.D. Miller, Jr., O.D. |
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Vol #: |
|
1 |
|
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|
C 8 |
|
Mark Dalton, O.D. |
|
Vol #: |
|
1 |
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C 9 |
|
Dale F. Hardy, O.D. |
|
Vol #: |
|
1 |
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C 10 |
|
Gregory J. Bruchs, O.D. |
|
Vol #: |
|
1 |
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|
2003D-0120
|
|
Multiplex
Tests for Heritable DNA Markers, Mutations & Expre |
|
|
|
C 1 |
|
Motorola Life Sciences |
|
Vol #: |
|
1 |
|
|
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|
2003D-0186 |
|
Guidance
for Industry: Use of Material From Deer and Elk In Animal Feed |
|
|
|
C 2 |
|
International Assn of Fish & Wildlife Agencies
|
|
Vol #: |
|
1 |
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C 3 |
|
National Grain & Feed Assn |
|
Vol #: |
|
1 |
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C 4 |
|
American Farm Bureau Federation |
|
Vol #: |
|
1 |
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2003N-0050 |
|
Investigational Device Exemptions Reports and
Records |
|
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|
N 2 |
|
FDA |
|
Vol #: |
|
1 |
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|
2003N-0169 |
|
Dental
Amalgam; Request for Information
|
|
|
|
ANS 1 |
|
HFA-305 to Mary ann Newell |
|
Vol #: |
|
1 |
|
|
|
|
|
C 7 |
|
Stuart Scheckner,DMD |
|
Vol #: |
|
1 |
|
|
|
|
|
C 8 |
|
Debbie Bevel |
|
Vol #: |
|
1 |
|
|
|
|
|
EC 21 |
|
Gatti, Antonietta |
|
Vol #: |
|
4 |
|
|
|
|
|
2003N-0201 |
|
Minimizing Medication Errors - Methods for Evaluating
Proprietary Names for their Confusion Potential; Public Meeting
|
|
|
|
NCR 1 |
|
FDA |
|
Vol #: |
|
1 |
|
|
|
|
|
NM 1 |
|
FDA |
|
Vol #: |
|
1 |
|
|
|
|
|
2003P-0067 |
|
Amend
CFR to include provision to establish prescription sun
|
|
|
|
PDN 1 |
|
HFC-1 to Robert M. Sayre, PhD & Ramon Fusaro,
MD.,PhD |
|
Vol #: |
|
1 |
|
|
|
|
|
2003P-0113 |
|
Levoxyl
(levothyroxine sodium) tablets (NDA #21-301) |
|
|
|
ACK 2 |
|
HFA-305 to Hogan & Hartson |
|
Vol #: |
|
1 |
|
|
|
|
|
PSA 1 |
|
Abbott Laboratories |
|
Vol #: |
|
1 |
|
|
|
|
|
2003P-0288 |
|
Health
Center, be deemed a " pharmacy of an other health care entity" |
|
|
|
ACK 1 |
|
HFA-305 to Family Care Health Center |
|
Vol #: |
|
1 |
|
|
|
|
|
CP 1 |
|
Family Care Health Centers |
|
Vol #: |
|
1 |
|
