AMIODARONE HYDROCHLORIDE | A077234 | HIKMA FARMACEUTICA (PORTUGAL) SA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Oxford Pharmaceuticals, LLC FDA-2019-P-3423 Oxford Pharmaceuticals, LLC filed a suitability petition under Section 505(j)(2)(c) of the Federal Food, Drug, and Cosmetic Act and 21 CFR 314.93 requesting that the FDA declare Baclofen Tablets, USP, 15mg suitable for submission via a supplemental Abbreviated New Drug Application. The proposed drug | Suitability | 2019-07-17 | Open | Oxford Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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