CHLORZOXAZONE | N011529 | JANSSEN RESEARCH AND DEVELOPMENT LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition Amendment from Pharmobedient Consulting LLC 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 | Suitability | 2024-07-01 | Open | — |
Suitability Petition from Pharmobedient Consulting, LLC 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 | Suitability | 2024-06-11 | Open | Pharmobedient Consulting |
Citizen Petition from Flamingo Pharmaceuticals Ltd 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the FDA determine whether PARAFON FORTE DSC (Chlorzoxazone Tablet 500mg), approved under NDA N011529, was voluntarily withdrawn for reasons unrelated to safety or efficacy, and if so, to designate an approved gene | 505(q) | 2015-11-20 | Granted | Flamingo Pharmaceuticals Ltd |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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