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U.S. Department of Health and Human Services

Regulatory Information

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2008 Chronological List of Petitions and Advisory Opinions

To view actual documents, make a note of the docket number, go to regulations.gov and enter the docket number in the search box. You will then get everything associated with that docket number.

Interim Response is not a final decision on the petition.

Date Filed Docket No. Name of Petition/Subject Matter Disposition
January      
01/02/2008 2008P-0001 Odan Laboratories, Inc./Determine that an abbreviated new drug application is suitable for a non- aerosol oral spray anesthetic delivering 10 mg lidocaine per metered dose.
Pending
01/02/2008 2005N-0279 Carolyn Smith/Food Labeling; Gluten-Free Labeling of Foods Pending
01/03/2008 2008P-0002 Cobe Chem Labs/Request to submit an Abbreviated New Drug Application for Tretinoin Cream in strength of 0.1%. Pending
01/03/2008 2008P-0003 Ebewe Pharma/Determine whether a 1 gm/20 mL (50 mg/mL) presentation of Fluorouracil Injection Pending
01/03/2008 2008P-0006 Lachman Consultant Services, Inc./To determine whether Didrex 25 mg (benzphetmine hydrochloride) Tablets (NDA 12-427) by Pharmacia and Upjohn Company, has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons Pending