BACLOFEN | N017851 | NOVARTIS PHARMACEUTICALS CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, PC FDA-2020-P-2067 · 6 docket documents The law firm Hyman, Phelps & McNamara, P.C., filed this suitability petition on behalf of a client under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93 to request that the FDA declare Baclofen Tablets, 15 mg, suitable for submission in an Abbreviated New Drug | Suitability | 2020-10-13 | Granted | Hyman, Phelps & McNamara, PC |
Suitability Petition from Oxford Pharmaceuticals, LLC FDA-2019-P-3423 · 3 docket documents 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, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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