MILNACIPRAN HYDROCHLORIDE | A205081 | AMNEAL PHARMACEUTICALS
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from MSN Laboratories Private Limited FDA-2025-P-2547 MSN Laboratories Private Limited filed this petition seeking a declaration from the FDA Commissioner that Abiraterone Acetate Tablets USP, 5000 mg, are suitable for submission as an Abbreviated New Drug Application (ANDA). The petitioner bases the request on the FDA's prior approval of an ANDA for A | Suitability | 2025-07-23 | Open | MSN Laboratories Private Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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