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| Dockets Entered
On April 1, 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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| 2003D-0493
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| Guidance on Powder Blends and Finished Dosage Units -- Stratified In-Process Dosage Unit Sampling and Assessmen
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| 2003N-0400
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| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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| 2003P-0291
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| Enforce the law and prevent unlaw sale of contact lens
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| 2003P-0365
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| Galderma product, solage containing 2% Mequinol, and 0.01% tretinoin, NDA 20-922 can be formulated as a topical solution with the substitution of Hydroquinone at 4% for the 2% mequinol as an ANDA
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| 2003P-0519
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| ANDA Suitability for Ondansetron Hydrochloride Injection and Ondansetron Hydrochloride Injection Premixed
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| 2003P-0544
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| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
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| 2004D-0002
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| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
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| 2004D-0028
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| Draft Consumer Advisory regarding Advice for Subgroups of a Population regarding Mercury in Fish and Shellfish
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| 2004D-0041
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| Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Content of Labeling
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| 2004M-0147
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| P890064/S009 - Digene Hybrid Capture 2 (HC2) High-Risk HPV DNA Test
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| 2004N-0086
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| Diabetes: Targeting Safe and Effective Prevention and Treatment; Public Meeting
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| 2004P-0003
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| Petition to reconsider the Food and Drug Administration's decision on the Med Watch complaint
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| 2004P-0006
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| Stay approval of abbreviated new drug applications for controlled release oxycodone hydrochloride products that list OxyContin oxycodone HCI controlled-release
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| 2004P-0032
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| ANADA for the Pioneer Products NADA 35-805 Aureo S 700 Type a medicated article ( Chlortetracycline, Sulfamethazine )
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| 2004P-0048
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| Abbreviated new drug application (ANDA) Suitability for Ondanaetron Hydrochloride Injection (8 mg/4 mL prefilled syringe)
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| 2004P-0054
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| Abbreviated New Drug Application (ANDA) for Doxycycline Hyclate Capsules, 75mg and 100 mg (NDA) 50-582
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| 2004P-0075
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| Prohibit the marketing and distribution of Authorized Generics until the expiraration of the first generic applicant's exclusivity period.
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| 2004P-0091
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| To premarket approval (PMA) for the gastric electrical stimulation ( GES), level III device, enterra therapy, for the treatment of severe nausea and vomiting from gastroparesis
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| 2004P-0157
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| ANDA Suitability for Amoxicillin and Clavulanate Potassium Tablets for Oral Suspension 200 mg/28.5 mg and 400 mg/57 mg
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| 2004V-0096
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| Laser Light Show
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| 2004V-0106
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| Laser Light Show
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
13477
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| Optimum Nutrition, Inc.
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| Vol #:
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| 111
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| LET
13478
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| Optimum Nutrition, Inc.
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| Vol #:
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| 111
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| LET
13479
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| Optimum Nutrition, Inc.
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| Vol #:
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| 111
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| LET
13480
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| Optimum Nutrition, Inc.
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| Vol #:
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| 111
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| LET
13481
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| Optimum Nutrition, Inc.
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| Vol #:
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| 111
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| LET
13482
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| Herbology Pty Ltds
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| Vol #:
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| 112
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| LET
13483
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| Neways Inc,
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| Vol #:
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| 112
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| LET
13484
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| Neways, Inc.
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| Vol #:
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| 112
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| LET
13485
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| Aboca USA Inc.
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| Vol #:
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| 112
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| 2003D-0493
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| Guidance on Powder Blends and Finished Dosage Units -- Stratified In-Process Dosage Unit Sampling and Assessmen
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| C
11
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| Upsher-Smith Laboratories, Inc.
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| Vol #:
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| 2
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| BKG
1
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| Definition of Comprehensive and Risk-Based
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| Vol #:
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| 4
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| BKG
2
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| Elements of an Animal Feed Safety System
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| Vol #:
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| 4
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| MM
1
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| Minutes of 9/23-24/2003 meeting prepared by Texas Tech University
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| Vol #:
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| 4
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| N
1
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| FDA
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| Vol #:
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| 4
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| 2003N-0400
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| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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| C
86
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| Creating GreenPiece.com
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| Vol #:
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| 9
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| C 87
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| 342 signatures
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| Vol #:
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| 9
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| C 88
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| J. Korsmo
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| Vol #:
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| 9
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| C 89
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| J. Korsmo
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| Vol #:
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| 9
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| SUP 1
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| J. Korsmo
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| Vol #:
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| 9
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| 2003P-0291
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| Enforce the law and prevent unlaw sale of contact lens
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| SUP
1
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| Assn of Regulatory Boards of Optometry (ARBO)
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| Vol #:
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| 2
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| 2003P-0365
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| Galderma product, solage containing 2% Mequinol, and 0.01% tretinoin, NDA 20-922 can be formulated as a topical solution with the substitution of Hydroquinone at 4% for the 2% mequinol as an ANDA
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| LET
2
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| Jerussi Consulting, Inc.
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| Vol #:
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| 1
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| 2003P-0519
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| ANDA Suitability for Ondansetron Hydrochloride Injection and Ondansetron Hydrochloride Injection Premixed
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| WDL
1
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| Abbott Laboratories, Inc.
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| Vol #:
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| 1
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| 2003P-0544
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| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
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| C 31
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| J. Liebenow
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| Vol #:
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| 2
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| C 32
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| J. Schraufnagel
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| Vol #:
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| 2
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| 2004D-0002
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| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
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| C
4
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| Wayne State University
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| Vol #:
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| 1
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| 2004D-0028
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| Draft Consumer Advisory regarding Advice for Subgroups of a Population regarding Mercury in Fish and Shellfish
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| C
28
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| HealthLink
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| Vol #:
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| 2
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| C 29
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| E. Nahan, Jr.
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| Vol #:
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| 1
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| 2004D-0041
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| Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Content of Labeling
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| C
1
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| Amersham Health, Inc.
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| Vol #:
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| 1
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| 2004M-0147
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| P890064/S009 - Digene Hybrid Capture 2 (HC2) High-Risk HPV DNA Test
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| AAV
1
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| Guidant Corporation
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| Vol #:
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| 1
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| 2004N-0086
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| Diabetes: Targeting Safe and Effective Prevention and Treatment; Public Meeting
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| C 1
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| S. Barlow,RD,CDE
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| Vol #:
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| 1
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| 2004P-0003
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| Petition to reconsider the Food and Drug Administration's decision on the Med Watch complaint
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| ACK 2
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| HFA-305 to Mr. Billy G. Pierson
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| Vol #:
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| 1
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| LET 2
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| B. Pierson
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| Vol #:
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| 1
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| PSA 1
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| Billy G. Pierson
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| Vol #:
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| 1
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| 2004P-0006
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| Stay approval of abbreviated new drug applications for controlled release oxycodone hydrochloride products that list OxyContin oxycodone HCI controlled-release
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| LET
1
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| HF-22 to Kleinfield, Kaplan and Becker, LLP
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| Vol #:
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| 2
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| 2004P-0032
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| ANADA for the Pioneer Products NADA 35-805 Aureo S 700 Type a medicated article ( Chlortetracycline, Sulfamethazine )
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| PAV
1
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| HFV-100 to PennField Oil Company
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| Vol #:
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| 1
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| 2004P-0048
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| Abbreviated new drug application (ANDA) Suitability for Ondanaetron Hydrochloride Injection (8 mg/4 mL prefilled syringe)
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| WDL
1
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| Abbott Laboratories
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| Vol #:
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| 2
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| 2004P-0054
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| Abbreviated New Drug Application (ANDA) for Doxycycline Hyclate Capsules, 75mg and 100 mg (NDA) 50-582
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| WDL
1
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| Mutual Pharmaceutical Company, Inc. (URL Mutual)
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| Vol #:
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| 1
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| 2004P-0075
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| Prohibit the marketing and distribution of Authorized Generics until the expiraration of the first generic applicant's exclusivity period.
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| C
1
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| Apotex Corp.
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| Vol #:
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| 1
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| 2004P-0091
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| To premarket approval (PMA) for the gastric electrical stimulation ( GES), level III device, enterra therapy, for the treatment of severe nausea and vomiting from gastroparesis
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| AMD
1
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| Gastroparcsis & Dysmotilities Assn. (GPDA)
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| Vol #:
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| 1
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| 2004P-0157
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| ANDA Suitability for Amoxicillin and Clavulanate Potassium Tablets for Oral Suspension 200 mg/28.5 mg and 400 mg/57 mg
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| ACK 1
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| HFA-305 to The Weinberg Group Inc.
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| Vol #:
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| 1
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| CP
1
Attachment
1, 2
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| The Weinberg Group Inc.
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| Vol #:
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| 1
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| 2004V-0096
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| Laser Light Show
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| VRA
1
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| HFZ-300 to Young Harris College
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| Vol #:
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| 1
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| 2004V-0106
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| Laser Light Show
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| VRA
1
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| HFZ-300 to High Tech Entertainment
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| Vol #:
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| 1
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