ACETAMINOPHEN; BUTALBITAL | A087811 | VALEANT PHARMACEUTICALS INTERNATIONAL
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Larken Laboratories, Inc. (Sovereign Pharmaceuticals, LLC) - Citizen Petition FDA-2011-P-0093 · 7 docket documents Sovereign Pharmaceuticals, LLC on behalf of Larken Laboratories, Inc. submitted an ANDA Suitability Petition under 21 CFR 314.93 requesting permission to file an abbreviated new drug application for Acetaminophen and Butalbital Tablets at a different strength (325 mg/25 mg) than the reference listed | Other | 2011-02-25 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.