ACETAZOLAMIDE

FDA-2026-P-4761 · 8 docket documents

Appco Pharma LLC filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting FDA approval to submit an Abbreviated New Drug Application for Acetazolamide Tablets, USP 500 mg, a strength that differs from the reference listed drug Diamox (approved

FDA-2020-P-2033 · 4 docket documents

The University of Kentucky Drug Quality Study team filed this citizen petition on September 30, 2019, requesting that the FDA recall identified lots of Mylan's Acetazolamide for Injection (NDC 67457-0853-50, Lot 7604764) on the grounds that the drug is adulterated under Section 501 of the Federal Fo

FDA-2014-P-0979 · 5 docket documents

Emcure Pharmaceuticals USA Inc. filed this citizen petition under 21 U.S.C. § 355(j)(2)(c) requesting that the FDA find that Duramed Pharmaceuticals/Barr (Teva) discontinued marketing of DIAMOX (Acetazolamide Injection 500mg base/vial), approved under NDA 009-388, for reasons unrelated to safety and

FDA-2013-P-1296 · 3 docket documents

Lannett Company, Inc. submitted this suitability petition under sections 505(j) of the Federal Food, Drug, and Cosmetic Act and 21 CFR 314.93 requesting that the FDA Commissioner determine that an Abbreviated New Drug Application may be filed for Acetazolamide Extended-Release Tablets using DIAMOX S