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| Dockets Entered
On June 14, 2004
Table of Contents
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| Docket #
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| Title
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| 2000D-1392
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| Guidance for Industry on Botanical Drug Products
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2002D-0509
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| Intl Conference on Harmonisation/M4 Common Technical Documen
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| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
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| 2004N-0018
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| Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
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| 2004P-0127
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| ANADA suitability for ANTIROBE (clindamycin hydrochloride) capsules for dogs and cats (NADA 120-161)
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| 2004P-0263
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| To declare that the drug Cefixine chewable tablets, 100 mg, 150 mg, and 200 mg are suitable for an abbreviated new drug application ( ANDA)
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| 2000D-1392
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| Guidance for Industry on Botanical Drug Products
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| GDL
2
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| Guideline
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| Vol #:
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| 1
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| NAD
2
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| FDA
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| Vol #:
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| 1
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| EXB 105
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| Center for Veterinary Medicine
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| Vol #:
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| 410
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| EXB 106
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| Center for Veterinary Medicine
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| Vol #:
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| 410
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| EXB 107
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| Center for Veterinary Medicine
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| Vol #:
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| 410
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| EXB 108
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| Center for Veterinary Medicine
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| Vol #:
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| 410
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| EXB 109
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| Center for Veterinary Medicine
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| Vol #:
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| 410
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| EXB 110
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| Center for Veterinary Medicine
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| Vol #:
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| 410
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| C 1357
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| Form Letter
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| Vol #:
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| 249
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| C 1358
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| Form Letter
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| Vol #:
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| 250
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| C 1359
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| Form Letter
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| Vol #:
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| 251
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| C 1360
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| Form Letter
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| Vol #:
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| 252
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| C 1361
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| Form Letter
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| Vol #:
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| 253
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| C 1362
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| Form Letter
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| Vol #:
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| 254
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| C 1363
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| Form Letter
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| Vol #:
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| 255
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| C 1364
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| Form Letter
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| Vol #:
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| 256
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| C 1365
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| Form Letter
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| Vol #:
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| 257
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| C 1366
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| Form Letter
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| Vol #:
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| 258
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| C 1367
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| Form Letter
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| Vol #:
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| 259
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| C 1368
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| Form Letter
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| Vol #:
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| 260
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| C 1369
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| Form Letter
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| Vol #:
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| 261
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| C 1370
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| Form Letter
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| Vol #:
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| 262
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| C 1371
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| Form Letter
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| Vol #:
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| 263
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| FONS
1
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| HFD-7
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| Vol #:
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| 3
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| NPR
1
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| FDA
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| Vol #:
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| 3
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| 2004N-0018
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| Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
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| NPR
1
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| FDA
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| Vol #:
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| 1
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| 2004P-0127
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| ANADA suitability for ANTIROBE (clindamycin hydrochloride) capsules for dogs and cats (NADA 120-161)
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| ACK 2
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| HFA-305 to Smart Drug Systems Inc.
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| Vol #:
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| 1
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| 2004P-0263
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| To declare that the drug Cefixine chewable tablets, 100 mg, 150 mg, and 200 mg are suitable for an abbreviated new drug application ( ANDA)
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| ACK 1
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| HFA-305 to Lupin Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| CP
1
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| Lupin Pharmaceuticals, Inc.
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| Vol #:
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| 1
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