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| Dockets Entered
On October 19, 2005
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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| 2000P-0586
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| Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz
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| 2003D-0367
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| Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format Human Pharmaceutical Applications and Related Submissions
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| 2003P-0464
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| ANDA for Clonazepam Oral Solution
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| 2004P-0252
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| ANDA Suitability for Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/700 mg, 7.5 mg/700 mg, and 10 mg/700 mg
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| 2005D-0240
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| Guidance for Industry on Development and Evaluation of Drugs for Treatment or Prevention of Gingivitis; Availability
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| 2005N-0413
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| Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments
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| 2005P-0048
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| Professional labeling for aspirin dosing in order to specify the morefavorable benefit/risk profile of aspirin doses of 75-150 mg/day for secondary cardiovascular prevention, 5-=150 mg/day for seconda
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| 2005P-0050
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| ANDA Suitability for Colistimethate Sodium 150 mg/2 mL Solution
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| 2005P-0383
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| refuse to approve any ANDA for generic oral products containing oxandrolone until the expiration od that exclusitity peroid on June 20, 2008.
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| 2005P-0418
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| Dextroamphetamine sulfate tablets, 2.5 mg,7.5 mg,15 mg,20 mg, and 30 mg suitable for submission as an ANDA
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| 2005P-0420
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| Establish therapeutic equivalence requirements for any generic or following-on drug product referencing Adderall XR MASP
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| 2005P-0421
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| To re-evaluate the prescribing information/package insert for new tramdol formulations in light of currently available safety information
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
16655
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| NBTY Inc.
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| Vol #:
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| 149
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| LET
16656
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| NBTY Inc.
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| Vol #:
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| 149
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| LET
16657
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| NBTY Inc.
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| Vol #:
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| 149
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| LET
16658
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| NBTY Inc.
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| Vol #:
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| 149
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| LET
16659
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| NBTY Inc.
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| Vol #:
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| 149
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| LET
16660
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| NBTY Inc.
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| Vol #:
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| 149
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| LET
16661
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| Instone, LLC
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| Vol #:
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| 149
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| LET
16662
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| Instone, LLC
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| Vol #:
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| 149
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| LET
16663
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| Perrigo Company of South Carolina
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| Vol #:
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| 149
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| LET
16664
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| Perrigo Company of South Carolina
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| Vol #:
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| 149
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| LET
16665
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| Natural Factors Nutritional Products Inc.
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| Vol #:
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| 149
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| LET
16666
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| PurPurdue Products L.P.
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| Vol #:
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| 149
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| LET
16667
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| Enzymatic Therapy
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| Vol #:
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| 149
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| LET
16668
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| Enzymatic Therapy
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| Vol #:
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| 149
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| LET
16669
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| Enzymatic Therapy
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| Vol #:
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| 149
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| LET
16670
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| Enzymatic Therapy
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| Vol #:
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| 149
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| 2000P-0586
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| Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz
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| BKG
1
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| Refs 1 - 67
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| Vol #:
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| 24
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| NPR
1
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| FDA
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| Vol #:
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| 24
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| 2003D-0367
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| Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format Human Pharmaceutical Applications and Related Submissions
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| GDL
2
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| Guideline
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| Vol #:
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| 1
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| NAD
2
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| FDA
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| Vol #:
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| 1
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| 2003P-0464
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| ANDA for Clonazepam Oral Solution
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| PAV
1
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| HFD-600 to Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| 2004P-0252
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| ANDA Suitability for Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/700 mg, 7.5 mg/700 mg, and 10 mg/700 mg
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| PAV
1
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| HFD-600 to Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| 2005D-0240
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| Guidance for Industry on Development and Evaluation of Drugs for Treatment or Prevention of Gingivitis; Availability
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| C 3
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| K. Donly, DDS, MS
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| Vol #:
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| 1
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| C 106
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| M. McCracken
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| Vol #:
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| 14
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| C 107
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| F. Pasko
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| Vol #:
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| 14
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| C 108
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| P. McGinley
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| Vol #:
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| 14
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| C 109
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| C. Wade
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| Vol #:
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| 14
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| C 110
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| G. Torrens
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| Vol #:
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| 14
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| C 111
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| J. Barzelatto, M.D.
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| Vol #:
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| 14
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| C 112
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| J Hutchinson et al.
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| Vol #:
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| 14
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| 2005N-0413
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| Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments
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| NM
1
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| FDA
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| Vol #:
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| 1
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| 2005P-0048
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| Professional labeling for aspirin dosing in order to specify the morefavorable benefit/risk profile of aspirin doses of 75-150 mg/day for secondary cardiovascular prevention, 5-=150 mg/day for seconda
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| C
5
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| American Heart Association
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| Vol #:
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| 3
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| 2005P-0050
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| ANDA Suitability for Colistimethate Sodium 150 mg/2 mL Solution
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| PAV
1
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| HFD-600 to Pharmaceutical Resources Group Consulting
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| Vol #:
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| 1
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| 2005P-0383
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| refuse to approve any ANDA for generic oral products containing oxandrolone until the expiration od that exclusitity peroid on June 20, 2008.
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| CR
1
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| Hyman, Phelps & McNamara, P.C.
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| Vol #:
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| 1
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| 2005P-0418
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| Dextroamphetamine sulfate tablets, 2.5 mg,7.5 mg,15 mg,20 mg, and 30 mg suitable for submission as an 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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| 2005P-0420
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| Establish therapeutic equivalence requirements for any generic or following-on drug product referencing Adderall XR MASP
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| ACK
1
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| HFA-305 to Shire Pharmaceuticals Group
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| Vol #:
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| 1
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| CP
1
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| Shire Pharmaceuticals Group
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| Vol #:
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| 1
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