BACLOFEN | N020075 | AMNEAL PHARMACEUTICALS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 1 - FDA Electronic Orange Book printout for Baclofen products Labe... FDA-2019-P-3423 Oxford Pharmaceuticals LLC filed this petition regarding baclofen tablets, specifically requesting clarification on the suitability of the Ivax/Teva baclofen tablet formulation for bioequivalence purposes under the abbreviated new drug application pathway. | Suitability | 2019-07-17 | Open | Oxford Pharmaceuticals LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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