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| Dockets Entered
On September 8, 2004
Table of Contents
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| Docket #
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| Title
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2003N-0342
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| Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products
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| 2004N-0355
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| Scientific Considerations Related to Developing Follow-on Protein Products
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| 2004P-0405
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| ANDA Suitability for Tramadol Hydrochloride Oral Solution, 50 mg per 5mL
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| 2004P-0406
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| ANDA for Betamethasone Sodium Phosphate and Betamethasone Acetate
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| 2004P-0407
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| ANDA for Bethamethasone Sodium Phosphate
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| 2004P-0409
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| metoclopramide hydrochloride orally disintegrating tablets 5 mg & 10 mg suitable for ANDA
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| 2004P-0411
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| Compel Enforcement and Regulation of Amyl Nitrate
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| RPT
235
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| Hormos Medical Corporation
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| Vol #:
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| 167
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| C 274
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| Hector Cervantes, DVM, MS, Dipl. ACPV
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| Vol #:
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| 99
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| 2003N-0342
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| Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products
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| C
11
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| Comision Federal Pars la Proteccion Contra Riegos Sanitarios, Mexico
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| Vol #:
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| 2
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| 2004N-0355
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| Scientific Considerations Related to Developing Follow-on Protein Products
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| NCR
1
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| FDA
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| Vol #:
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| 1
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| 2004P-0405
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| ANDA Suitability for Tramadol Hydrochloride Oral Solution, 50 mg per 5mL
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| ACK
1
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| HFA-305 to Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| CP
1
Attachment A,
B,
C
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| Lachman Consultant Services, Inc.
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| 1
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| 2004P-0406
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| ANDA for Betamethasone Sodium Phosphate and Betamethasone Acetate
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| ACK
1
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| HFA-305 to Hikma Farmaceutica (Portugal), Lda
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| Vol #:
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| 1
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| CP
1
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| Hikma Farmaceutica (Portugal), Lda
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| Vol #:
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| 1
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| 2004P-0407
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| ANDA for Bethamethasone Sodium Phosphate
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| ACK
1
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| HFA-305 to Hikma Farmaceutica (Portugal), Lda
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| Vol #:
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| 1
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| CP
1
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| Hikma Farmaceutica (Portugal), Lda
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| Vol #:
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| 1
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| 2004P-0409
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| metoclopramide hydrochloride orally disintegrating tablets 5 mg & 10 mg suitable for ANDA
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| CP
1
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| Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| 2004P-0411
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| Compel Enforcement and Regulation of Amyl Nitrate
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| ACK
1
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| HFA-305 to Gerald Austin
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| Vol #:
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| 1
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