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FDA-2023-P-5094 · 10 docket documents

Cardinal Health Regulatory Sciences filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Voriconazole Injection, 200 mg/20 mL (10 mg/mL), a ready-to-use solution, suitable for an abbreviated new drug application based

FDA-2021-P-0342 · 10 docket documents

Cardinal Health Regulatory Sciences filed this petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Voriconazole Injection, 200 mg/10 mL (10 mg/mL), suitable for consideration in an ANDA. The proposed ready-to-use solution differs from

FDA-2017-P-3329 · 4 docket documents

Hyman, Phelps & McNamara, P.C. filed this petition on behalf of Xellia Pharmaceutical ApS and Xellia Pharmaceuticals USA, LLC requesting that FDA assign a Therapeutic Equivalence Evaluation Code of "AP" in the Orange Book for Xellia's Voriconazole for Injection, 200 mg/vial, approved under NDA 20856

FDA-2013-P-0203 · 4 docket documents

Merchant & Gould P.C. filed this citizen petition on behalf of a client on February 15, 2013, requesting that the FDA waive the "non-exception excipient" requirements under 21 CFR 314.94(a)(9)(iii) and 314.127(a)(8)(ii)(B) to permit submission of an abbreviated new drug application (ANDA) under sect