PARAFON FORTE DSC

FDA-2024-P-2778

Pharmobedient Consulting LLC filed a suitability petition (FDA-2024-P-2778) seeking FDA determination that Chlorzoxazone Orally Disintegrating Tablets in 250 mg and 500 mg strengths are suitable for submission in an ANDA under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act, based o

FDA-2024-P-2778

Pharmobedient Consulting, LLC filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Chlorzoxazone Orally Disintegrating Tablets in 250 mg and 500 mg strengths suitable for submission in an Abbreviated New Drug Applicati

FDA-2019-P-5759

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

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-2015-P-4224

Flamingo Pharmaceuticals Ltd. filed this petition under section 505(g) requesting that the FDA determine whether PARAFON FORTE DSC (Chlorzoxazone Tablet 500mg), approved under NDA N011529, was voluntarily withdrawn for reasons unrelated to safety or efficacy, and if so, to designate an approved gene

FDA-2015-P-3942

REGCON Solutions filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate Mikart's Chlorzoxazone Tablets, 750 mg (ANDA 040861) as a reference-listed drug in the Orange Book to enable generic competition, since the currently design

FDA-2013-P-0671

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whether PARAFLEX (chlorzoxazone) Tablets, 250 mg, approved under NDA 011300 by Ortho McNeil Pharm, was voluntarily withdrawn from sale for safety or effectiveness reasons pursuant to 21 C.F.R. § 314.161 a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

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