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| Dockets
Entered On February 17, 2004
Table of Contents
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| Docket #
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| Title
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| 1988N-0258
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| Prescription Drug Marketing Act of 1987; Guideline
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| 1992N-0297
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| Prescription Drug Marketing Act of 1987, Drug Amds of 1992
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 2000N-1449
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| Changes to an Approved NDA or ANDA; Agency Information Collection
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| 2000N-1531
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| Proposal to Debar Bruce I Diamond PhD, Opportunity for Heari
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2002N-0276
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| Bioterrorism Preparedness; Registration of Food Facilities
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| 2002P-0233
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| Hydrocodone Bitartrate/Acetaminophen orally 5mg/500mg ANDA
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| 2002P-0245
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| ANDA for Fludarabine Phosphate Injection, 25 mg/ML
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| 2003P-0064
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| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| 2003P-0363
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| Professional and Patient Labeling for Hearing Aid Devices
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| 2004P-0060
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| Health Claim Petition: Glucosamine Sulfate and Osteoarthritis
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| 2004P-0068
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| Establish specific bioequivalence requirements for oral products contanining desmopressin
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| 2004P-0069
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| Declare that Fentanyl Transdermal Systems, in strengths of 37.5 mcg/hr, 62.5 mcg/hr, and 87.5 mcg/hr are suitable for submission in an ANDA
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| 1988N-0258
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| Prescription Drug Marketing Act of 1987; Guideline
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| CR
2
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| Kleinfeld, Kaplan & Becker, LLP
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| Vol #:
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| 6
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| 1992N-0297
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| Prescription Drug Marketing Act of 1987, Drug Amds of 1992
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| CR
2
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| Kleinfeld, Kaplan & Becker, LLP
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| Vol #:
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| 8
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
12670
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| NBTY Inc.
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| Vol #:
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| 103
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| LET
12671
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| NBTY Inc.
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| Vol #:
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| 103
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| LET
12672
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| NBTY Inc.
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| Vol #:
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| 103
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| LET
12673
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| NBTY Inc.
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| Vol #:
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| 103
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| LET
12674
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| Your Vitamins
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| Vol #:
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| 103
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| LET
12675
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| Your Vitamins
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| Vol #:
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| 103
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| LET
12676
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| NBTY Inc.
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| Vol #:
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| 103
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| LET
12677
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| NBTY Inc.,
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| Vol #:
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| 103
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| LET
12678
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| NBTY Inc.
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| Vol #:
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| 103
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| LET
12679
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| NBTY Inc.
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| Vol #:
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| 103
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| LET
12680
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| NBTY Inc.
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| Vol #:
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| 103
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| LET
12681
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| NBTY Inc.
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| Vol #:
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| 103
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| LET
12682
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| NBTY Inc.
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| Vol #:
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| 103
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| 2000N-1531
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| Proposal to Debar Bruce I Diamond PhD, Opportunity for Heari
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| SUP 2
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| Bruce I. Diamond
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| Vol #:
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| 2
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| C 357
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| A. Halterlein
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| Vol #:
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| 162
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| C 358
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| K. Visvardis
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| Vol #:
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| 162
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| C 359
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| R. Claypoole
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| Vol #:
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| 162
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| C 360
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| 8 signatures
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| Vol #:
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| 162
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| 2002N-0276
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| Bioterrorism Preparedness; Registration of Food Facilities
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| C
217
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| Chilean Exporters Assn (ASOEX)
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| Vol #:
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| 20
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| 2002P-0233
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| Hydrocodone Bitartrate/Acetaminophen orally 5mg/500mg ANDA
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| LET
1
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| HFD-601 to Kleinfeld, Kaplan and Backer
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| Vol #:
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| 1
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| 2002P-0245
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| ANDA for Fludarabine Phosphate Injection, 25 mg/ML
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| LET
1
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| HFD-601 to Gensia Sicor Pharmaceuticals
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| Vol #:
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| 1
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| SUP
1
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| Sicor Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2003P-0064
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| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
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| SUP
1
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| Aventis Pharmaceuticals, Inc. (Aventis)
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| Vol #:
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| 4
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| EMC
41
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| America's Hearing Healthcare Team
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| Vol #:
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| 2
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| PDN
1
Attachment
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| HFZ-1 to Etymotic Research, Inc
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| Vol #:
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| 2
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| 2003P-0363
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| Professional and Patient Labeling for Hearing Aid Devices
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| EMC
18
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| America's Hearing Healthcare Team
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| Vol #:
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| 1
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| PDN
1
Attachment
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| HFZ-1 to Gudhear, Inc
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| Vol #:
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| 1
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| 2004P-0060
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| Health Claim Petition: Glucosamine Sulfate and Osteoarthritis
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| CP
1
Original
Submission
Attachments
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| Rotta Pharmaceuticals Inc
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| Vol #:
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| 1
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| LET
1
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| HFS-255to Hogan & Hartson LLP
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| Vol #:
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| 3
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| LET
2
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| Rotta Pharmaceuticals Inc
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| Vol #:
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| 4
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| LET
3
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| Rotta Pharmaceuticals Inc
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| Vol #:
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| 3
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| LET
4
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| Rotta Pharmaceuticals Inc
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| Vol #:
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| 3
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| LET
5
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| Rotta Pharmaceuticals Inc
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| Vol #:
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| 3
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| LET
6
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| HFS-200 to Hogan & Hartson LLP
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| Vol #:
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| 3
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| 2004P-0068
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| Establish specific bioequivalence requirements for oral products contanining desmopressin
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| ACK 1
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| HFA-305 to Ferring Pharmaceutical, Inc.
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| Vol #:
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| 1
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| CP
1
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| Ferring Pharmaceuticals, Inc
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| Vol #:
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| 1
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| 2004P-0069
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| Declare that Fentanyl Transdermal Systems, in strengths of 37.5 mcg/hr, 62.5 mcg/hr, and 87.5 mcg/hr are suitable for submission in an ANDA
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| ACK 1
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| HFA-305 to Lachman Consultant Service, Inc.
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| Vol #:
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| 1
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| CP
1
Attachment
1, 2,
3
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| Lachman Consultant Service, Inc.
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| Vol #:
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| 1
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