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FDA-1989-P-0176 · 4 docket documents

Du Pont Pharmaceuticals submitted this citizen petition on January 25, 1989, requesting that the FDA Commissioner rule that an Abbreviated New Drug Application is acceptable for clindamycin phosphate injection USP at 150 mg/mL in 50 mL and 100 mL polyvinyl chloride containers. The petitioner argued

FDA-1992-P-0105 · 5 docket documents

Guidelines, Inc. filed this petition under 21 USC 710(a) and 505(j)(2)(A) requesting that the FDA extend the List of Drug Products Suitable for Abbreviated New Drug Applications to include clindamycin phosphate topical lotion in a new dosage form consisting of individually packaged foil-covered satu

FDA-2009-P-0120 · 3 docket documents

Stiefel Laboratories, Inc., through counsel at Buchanan Ingersoll & Rooney, filed this citizen petition under section 505(j) of the Federal Food, Drug and Cosmetic Act regarding Evoclin (clindamycin phosphate 1% topical aerosol foam), NDA 50-801, to request that FDA clarify and apply the 30-month st

FDA-2006-P-0267 · 5 docket documents

E. Tanghetti, MD, filed this petition on December 15, 2006, requesting that the FDA withdraw approval of and recall Ziana, a topical combination product containing clindamycin phosphate 1.2% and tretinoin 0.025%, or alternatively require long-term safety studies to evaluate antibiotic resistance ass

FDA-2007-P-0059 · 5 docket documents

Olsson, Frank and Weeda, P.C. filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting permission to submit an abbreviated new drug application for clindamycin phosphate foam in a non-aerosol, pump-dispensed dosage form differing from the referenc