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| Dockets Entered
November 18, 2004
Table of Contents
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2003F-0471
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| Filing of Food Additive Petition (FAP 3A4749)
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| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
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| 2003P-0574
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| Regulatory limit for Listeria monocytogenes in ready-to-eat foods that do not support its growth
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| 2004N-0264
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| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
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| 2004N-0355
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| Scientific Considerations Related to Developing Follow-on Protein Products
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| 2004P-0051
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| Dyclone (dyclonine hydrochloride) Topical Solution 0.5% and 1.0% (NDA 9-925) was voluntarily withdrawn or withheld from sale for reasons other then safety or efficacy
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| 2004P-0239
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| Issue a Final and Complete Guidance Document to Determine Bioequivalence (BE) for Nasal Spray Products.
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| 2004P-0411
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| Compel Enforcement and Regulation of Amyl Nitrate
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| 2004P-0514
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| Selegiline Hydrochloride Orally Disintegrating Tablets, 5mg for an abbreviated new drug application (ANDA)
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
14797
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| McLind Corporation
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| Vol #:
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| 130
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| LET
14798
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| McLind Corporation
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| Vol #:
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| 130
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| LET
14799
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| McLind Corporation
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| Vol #:
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| 130
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| LET
14800
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| McLind Corporation
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| Vol #:
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| 130
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| LET
14801
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| McLind Corporation
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| Vol #:
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| 130
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| LET
14802
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| McLind Corporation
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| Vol #:
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| 130
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| LET
14803
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| McLind Corporation
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| Vol #:
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| 130
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| LET
14804
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| McLind Corporation
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| Vol #:
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| 130
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| LET
14805
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| New Chapter, Inc.
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| Vol #:
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| 130
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| LET
14806
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| New Chapter, Inc.
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| Vol #:
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| 130
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| LET
14807
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| New Chapter, Inc.
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| Vol #:
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| 130
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| LET
14808
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| New Chapter, Inc.
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| Vol #:
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| 130
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| LET
14809
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| Enzymatic Therapy
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| Vol #:
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| 130
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| LET
14810
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| Enzymatic Therapy
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| Vol #:
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| 130
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| LET
14811
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| Enzymatic Therapy
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| Vol #:
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| 130
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| LET
14812
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| Enzymatic Therapy
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| Vol #:
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| 130
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| EXB 696
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| Bayer Corporation
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| Vol #:
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| 462
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| EXB 697
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| Bayer Corporation
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| Vol #:
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| 462
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| EXB 698
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| Bayer Corporation
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| Vol #:
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| 462
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| EXB 699
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| Bayer Corporation
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| Vol #:
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| 462
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| EXB 700
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| Bayer Corporation
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| Vol #:
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| 462
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| EXB 701
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| Bayer Corporation
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| Vol #:
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| 462
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| EXB 702
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| Bayer Corporation
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| Vol #:
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| 462
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| EXB 703
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| Bayer Corporation
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| Vol #:
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| 462
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| EXB 704
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| Bayer Corporation
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| Vol #:
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| 462
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| EXB 705
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| Bayer Corporation
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| Vol #:
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| 462
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| EXB 706
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| Bayer Corporation
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| Vol #:
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| 462
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| EXB 707
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| Bayer Corporation
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| Vol #:
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| 462
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| EXB 708
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| Bayer Corporation
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| Vol #:
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| 462
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| EXB 709
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| Bayer Corporation
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| Vol #:
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| 462
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| EXB 710
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| Bayer Corporation
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| Vol #:
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| 462
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| EXB 711
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| Bayer Corporation
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| Vol #:
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| 462
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| 2003F-0471
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| Filing of Food Additive Petition (FAP 3A4749)
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| C
1
Attachment 1,
2, 3,
4, 5
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| Hercules Incorporated
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| Vol #:
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| 1
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| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
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| SUP
9
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| American Thoracic Society (ATS)
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| Vol #:
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| 6
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| 2003P-0574
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| Regulatory limit for Listeria monocytogenes in ready-to-eat foods that do not support its growth
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|
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| C
10
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| Star Food Products, Inc.
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| Vol #:
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| 2
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| 2004N-0264
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| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
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|
|
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| C 195
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| J. Espoz
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| Vol #:
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| 23
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| 2004N-0355
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| Scientific Considerations Related to Developing Follow-on Protein Products
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| C
7
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| Plasma Protein Therapeutics Assn (PPTA)
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| Vol #:
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| 4
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| 2004P-0051
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| Dyclone (dyclonine hydrochloride) Topical Solution 0.5% and 1.0% (NDA 9-925) was voluntarily withdrawn or withheld from sale for reasons other then safety or efficacy
|
|
|
|
|
| LET
2
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| HFD-007 to Arent Fox, PLLC
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| Vol #:
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| 1
|
|
|
|
|
| 2004P-0239
|
| Issue a Final and Complete Guidance Document to Determine Bioequivalence (BE) for Nasal Spray Products.
|
|
|
|
|
| LET
1
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| HFD-005 to GlaxoSmithKline (GSK)
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| Vol #:
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| 2
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| 2004P-0411
|
| Compel Enforcement and Regulation of Amyl Nitrate
|
|
|
|
|
| SUP 1
|
| H. Wilson
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| Vol #:
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| 2
|
|
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| 2004P-0514
|
| Selegiline Hydrochloride Orally Disintegrating Tablets, 5mg for an abbreviated new drug application (ANDA)
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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 1,
2, 3
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| Lachman Consultant Services Inc.
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| Vol #:
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| 1
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