CHLORZOXAZONE | A089895 | BARR LABORATORIES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
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the FDA determine whether PARAFON FORTE DSC (Chlorzoxazone Tablet 500mg), approved under NDA N011529, was voluntarily withdrawn for reasons unrelated to safety or efficacy, and if so, to designate an approved gene | 505(q) | 2015-11-20 | Granted | Flamingo Pharmaceuticals Ltd |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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