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| Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format Human Pharmaceutical Applications and Related Submissions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