PARAFLEX

FDA-2025-P-0344 · 8 docket documents

Pharmobedient Consulting, LLC filed a suitability petition pursuant to section 505(j)(2)(C) of the FDC Act and 21 C.F.R. § 314.93 requesting that the FDA declare Chlorzoxazone Tablets, 125 mg suitable for submission in an ANDA, which differs in strength from the reference listed drug Paraflex (Chlor

FDA-2019-P-5759 · 8 docket documents

Aavis Pharmaceuticals filed this petition on December 6, 2019, requesting that the FDA determine a new fixed-dose combination of Chlorzoxazone 250 mg and Acetaminophen 300 mg tablets is suitable for submission of an Abbreviated New Drug Application under section 505(j)(2)(C) of the Federal Food, Dru

FDA-1991-P-0002 · 8 docket documents

Mikart, Incorporated filed this citizen petition under 21 U.S.C. 505(j)(2)(A) and (C) requesting that the FDA amend the List of Drug Products Suitable for Abbreviated New Drug Applications to include chlorzoxazone 750 mg tablets, which would provide greater prescribing flexibility by being divisible

FDA-2013-P-0671 · 4 docket documents

Lachman Consultant Services, Inc. filed this citizen petition requesting that the FDA determine whether PARAFLEX (chlorzoxazone) Tablets, 250 mg, approved under NDA 011300 by Ortho McNeil Pharm, was voluntarily withdrawn from sale for safety or effectiveness reasons pursuant to 21 C.F.R. § 314.161 a

FDA-1995-P-0005 · 13 docket documents

The Food and Drug Administration is withdrawing approval of 128 suitability petitions under the Pediatric Research Equity Act of 2003, a regulatory mechanism that permits abbreviated new drug applications for drugs with different active ingredients, dosage forms, or routes of administration than the