ACETAMINOPHEN; BUTALBITAL | A089568 | HALSEY DRUG CO INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Lachman Consultant Services, Inc. - Citizen Petition FDA-2011-P-0167 Lachman Consultant Services, Inc., on behalf of a client, filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Butalbital and Acetaminophen Capsules 50 mg/300 mg suitable for submission as an abbreviated new drug applicati | Other | 2011-03-25 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.