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| Dockets Entered
On October 16, 2003
Table of Contents
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| Docket #
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| Title
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| 2002P-0478
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| Fentanyl transdermal system 12.5 mcg/hr is suitable for ANDA
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| 2003D-0319
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| Guidance for Industry and FDA Staff; Draft; Premarket Assessment of Pediatric Medical Devices
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| 2003D-0367
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| Draft Guidance for Industry on Providing Regulatory Submissions in Electronic FormatbHuman Pharmaceutical Applications and Related Submissions
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| 2003D-0385
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| Guidance for Industry: Comparability Protocols b
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| 2003N-0338
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| Obesity
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| 2003N-0429
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| Prescription Drug User Fee Act (PDUFA) III Five-Year Plan; Availability
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| 2003P-0436
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| (ANDA) containing 300 mg Acetaminophen/ 5 mg Hydrocodone, 300 mg Acetaminophen/ 7.5 mg Hydrocodone, 300 mg Acetaminophen/ 10 mg Hydrocodone
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| 2003P-0464
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| ANDA for Clonazepam Oral Solution
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| 2002P-0478
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| Fentanyl transdermal system 12.5 mcg/hr is suitable for ANDA
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| WDL
1
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| Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| 2003D-0319
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| Guidance for Industry and FDA Staff; Draft; Premarket Assessment of Pediatric Medical Devices
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| C
2
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| Philips Medical Systems
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| 1
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| 2003D-0367
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| Draft Guidance for Industry on Providing Regulatory Submissions in Electronic FormatbHuman Pharmaceutical Applications and Related Submissions
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| C
1
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| Aventis Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2003D-0385
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| Guidance for Industry: Comparability Protocols b
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| C
1
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| Millennium Pharmaceuticals, Inc.
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| 1
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| 2003N-0338
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| Obesity
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| C
4
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| Judy Murnan,MPH
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| 1
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| 2003N-0429
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| Prescription Drug User Fee Act (PDUFA) III Five-Year Plan; Availability
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| RPT
1
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| Background Material
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| 1
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| 2003P-0436
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| (ANDA) containing 300 mg Acetaminophen/ 5 mg Hydrocodone, 300 mg Acetaminophen/ 7.5 mg Hydrocodone, 300 mg Acetaminophen/ 10 mg Hydrocodone
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| LET
1
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| HFD-600 to Anabolic Laboratories, Inc.
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| 1
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| 2003P-0464
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| ANDA for Clonazepam Oral Solution
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| AMD
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| Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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