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| Dockets Entered
On December 26, 2006
Table of Contents
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| Docket #
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| Title
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| 1977N-0094L
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| Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment ot the Tentative Final Monograph; Required Warnings and Other Labeling
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| 1978N-0065
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| Skin Bleaching Drug Products
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| 1999V-0184
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| Variance Laser Light Show Projector Model #LP1
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| 2000V-1469
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| Laser Light Show
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| 2004P-0324
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| ANDA filed by Ivax Pharmaceuticals for a generic formulation of DuoNeb subject to a 30-month stay of approval
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| 2005P-0265
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| Over-the Counter Sale of Modafinil
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| 2005P-0291
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| ANDA or Section 505(b)(2),for inhalation drug products containing a combination of active ingredients albuterol sulfate and ipratropium hydrochloride
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| 2006D-0226
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| Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part 203; Effective Date and Compliance Policy GuideProgram, Draft Guidance; Availability
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| 2006D-0344
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| Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling
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| 2006D-0363
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| Guidance for Industry and Food and Drug Administration Staff; Draft Class II Special Controls Guidance Document: Absorbable Hemostatic Device
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| 2006D-0408
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| Guidance for Industry and Food and Drug Administration Staff; Annual Reports for Approved Premarket Approval Applications
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| 2006E-0332
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| Patent Extension Application for NAMENDA (memantine hydrochloride), U.S. Patent No. 5,061,703
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| 2006E-0333
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| Patent Extension Application for NAMENDA (memantine hydrochloride), U.S. Patent No. 5,614,560
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| 2006E-0532
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| Patent Extension Application for Anthelios SX Daily Moisturizing Cream With Sunscreen, U.S. Patent No. 4,585,597
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| 2006M-0529
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| P060010 - The Spanner Temporary Prostatic Stent
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| 2006M-0530
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| P040025 - Olympic Cool-Cap
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| 2006M-0531
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| P050033 - Cosmetic Tissue Augmentation Product
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| 2006N-0062
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| Expanded Access to Investigational Drugs for Treatment Use
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| 2006N-0362
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| General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device
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| 2006N-0464
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| Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing
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| 2006P-0085
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| To Exempt the Class II device Cranial Orthoses from Premarket Notification Requirements
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| 2006P-0397
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| Permit an ANDA Suitability for Fexofenadine Hydrochloride for Oral Suspension
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| 2006P-0410
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| Refuse to approve any ANDA for amifostine product with labeling which omits dosage and other information
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| 1977N-0094L
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| Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment ot the Tentative Final Monograph; Required Warnings and Other Labeling
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| NPR
2
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| FDA
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| Vol #:
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| 1
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| 1978N-0065
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| Skin Bleaching Drug Products
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| EC
499
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| Mrs. Gwendolynn Frazier
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| Vol #:
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| 19
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| EC
500
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| Mrs. Vivian Beaty
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| Vol #:
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| 19
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| EC
501
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| Mrs. Tina Pipes
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| Vol #:
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| 19
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| EC
502
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| Ms. Debbi Herr
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| Vol #:
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| 19
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| EC
503
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| Monterey Laser and Skin Care
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| Vol #:
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| 19
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| EC
504
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| Dr. Ruey Yu
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| Vol #:
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| 19
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| PDN 1
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| FDA/CDER to James Salsman
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| Vol #:
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| 1
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| 2005P-0291
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| ANDA or Section 505(b)(2),for inhalation drug products containing a combination of active ingredients albuterol sulfate and ipratropium hydrochloride
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| PDN 1
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| FDA/CDER to Charles J. Raubicheck
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| Vol #:
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| 1
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| 2006D-0226
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| Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part 203; Effective Date and Compliance Policy GuideProgram, Draft Guidance; Availability
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| EC 11
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| Mrs. Debra Orellana
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| Vol #:
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| 1
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| 2006D-0344
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| Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling
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| C 12
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| Roche Pharmaceuticals
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| Vol #:
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| 1
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| 2006D-0363
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| Guidance for Industry and Food and Drug Administration Staff; Draft Class II Special Controls Guidance Document: Absorbable Hemostatic Device
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| EXT 1
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| Ethicon, Inc.
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| Vol #:
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| 1
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| 2006D-0408
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| Guidance for Industry and Food and Drug Administration Staff; Annual Reports for Approved Premarket Approval Applications
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| C 1
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| St. Jude Medical
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| Vol #:
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| 1
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| 2006E-0332
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| Patent Extension Application for NAMENDA (memantine hydrochloride), U.S. Patent No. 5,061,703
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| APP 1
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| Forest Laboratories, Inc.
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| Vol #:
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| 1
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| CR 1
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| LET 1
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| U.S. Patent and Trademark Office to FDA/CDER
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| Vol #:
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| 1
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| 2006E-0333
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| Patent Extension Application for NAMENDA (memantine hydrochloride), U.S. Patent No. 5,614,560
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| APP 1
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| Forest Laboratories, Inc.
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| Vol #:
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| 1
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| LET 1
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| U.S. Patent & Trademark Office to FDA/CDER (HFD-13)
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| Vol #:
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| 1
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| LET 2
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| U.S. Patent & Trademark Office to FDA/CDER (HFD-7)
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| Vol #:
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| 1
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| 2006E-0532
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| Patent Extension Application for Anthelios SX Daily Moisturizing Cream With Sunscreen, U.S. Patent No. 4,585,597
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| APP 1
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| L'Oreal S.A.
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| Vol #:
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| 1
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| LET 1
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| U.S. Patent and Trademark Office to FDA/CDER (HFD-7)
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| Vol #:
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| 2
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| 2006M-0529
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| P060010 - The Spanner Temporary Prostatic Stent
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| AAV 1
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| AbbeyMoor Medical, Inc.
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| Vol #:
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| 1
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| 2006M-0530
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| P040025 - Olympic Cool-Cap
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| AAV 1
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| Olympic Medical
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| Vol #:
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| 1
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| 2006M-0531
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| P050033 - Cosmetic Tissue Augmentation Product
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| AAV 1
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| Anika Therapeutics, Inc.
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| Vol #:
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| 1
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| 2006N-0062
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| Expanded Access to Investigational Drugs for Treatment Use
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| EC 5
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| SUNY at Stony Brook
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| Vol #:
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| 1
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| 2006N-0362
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| General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device
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| EXT 2
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| Ethicon, Inc.
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| Vol #:
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| 1
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| 2006N-0464
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| Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing
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| EC 28
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| Cyber Security Industry Alliance
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| Vol #:
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| 2
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| 2006P-0085
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| To Exempt the Class II device Cranial Orthoses from Premarket Notification Requirements
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| N 2
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| FDA
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| Vol #:
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| 2
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| EC
453
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| Ms. Sophia DiPietro
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| Vol #:
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| 7
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| 2006P-0397
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| Permit an ANDA Suitability for Fexofenadine Hydrochloride for Oral Suspension
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| C 1
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| Sanofi-Aventis, U. S. (Sanofi)
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| Vol #:
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| 1
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| 2006P-0410
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| Refuse to approve any ANDA for amifostine product with labeling which omits dosage and other information
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| C 2
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| Sun Pharmaceutical Industries, Ltd.
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| Vol #:
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| 1
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