CHLORZOXAZONE | A040113 | ACTAVIS ELIZABETH LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Aavis Pharmaceuticals 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 | Other | 2019-12-06 | Denied | Aavis Pharmaceuticals |
Citizen Petition from Mikart, Inc. 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 | Other | 2018-01-04 | Granted | Mikart, Inc. |
Withdrawal of Approval of 128 Suitability Petitions 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 | Safety Withdrawal | 2007-03-06 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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