OXANDROLONE

FDA-2022-P-0558 · 4 docket documents

Novitium Pharma LLC filed this relisting petition under 21 C.F.R. §10.25(a), §10.30, and Sections 505(j) and 505(w) of the FDC Act requesting that the FDA determine whether OXANDRIN (oxandrolone tablets, USP) 2.5 mg and 10 mg, NDA 013718, owned by Gemini Laboratories LLC, was voluntarily withdrawn f

FDA-2019-P-3907 · 4 docket documents

Novitium Pharma LLC filed this citizen petition under 21 CFR § 10.30 requesting that the FDA designate the generic product made by PAR Pharmaceutical Inc (ANDA A077827) as the reference standard for Oxandrin (oxandrolone) Tablets 2.5mg and 10mg (NDA 013718), since the brand manufacturer Gemini Labor

FDA-2019-P-1980 · 7 docket documents

Novitium Pharma LLC filed this citizen petition under 21 C.F.R. § 10.30 requesting that the FDA designate PAR Pharmaceutical Inc's generic product (ANDA A077827) as the reference standard for Oxandrin (Oxandrolone) Tablets 2.5mg and 10mg (NDA 013718), since the original brand manufacturer Gemini Lab

FDA-2018-P-3422 · 6 docket documents

Novitium Pharma LLC filed this citizen petition under 21 CFR 10.30 requesting that the FDA designate PAR Pharmaceutical Inc's generic product (ANDA A077827) as the reference standard for Oxandrin (Oxandrolone) Tablets 2.5mg and 10mg (NDA 013718), because the original brand manufacturer Gemini Labora

FDA-2005-P-0368 · 10 docket documents

Buchanan Ingersoll, on behalf of Savient Pharmaceuticals, Inc., filed this petition under 505(j) of the Federal Food, Drug and Cosmetic Act requesting that the FDA verify and protect Savient's three-year market exclusivity for geriatric dosing information and clinical studies data for Oxandrin (oxan