Pharmaceutical Policy

Dockets

• Requests that the FDA determine whether the Reference Listed Drug (RLD) SPORANOX (ITRACONAZOLE) Oral Solution, 10mg/mL; under New Drug Application (NDA) N020657 held by JANSSEN PHARMACEUTICALS INC, was voluntarily withdrawn from commercial distribution, or withdrawn from sale for safety or efficacy reasons.FDA
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• Requests that the FDA refrain from approving any ANDA submitted pursuant to an approved suitability petition under section 505(j)(2)(C) of the FD&C Act for dabrafenib mesylate capsules, 150 mg (EQ Base), unless and until the applicant has conducted and submitted to the FDA.FDAOpen
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• Request that the FDA declare that the drug product, generic ivermectin (1.87%) oral liquid is suitable for submission in an Abbreviated New Animal Drug Application (ANADA)FDA
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• Requests that the FDA declare that an ANDA may be submitted for, Modafinil Tablets, USP 50 mg and 150 mg, 2 strengths that differ from the currently approved RLD, PROVIGIL (Modafinil) tablets from NUVO PHARMACEUTICALS (IRELAND) DAC, which FDA approved in 100 mg and 200 mg strengths on Dec 24th, 1998 under NDA #020717.FDA
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