CARBAMAZEPINE | A205571 | ZYDUS PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Axinn on behalf of Zydus Pharmaceuticals (USA) Inc. FDA-2019-P-3545 Axinn, on behalf of Zydus Pharmaceuticals (USA) Inc., filed this citizen petition under Section 505 of the FD&C Act requesting that FDA require pending and approved abbreviated new drug applications for Carbamazepine Extended Release Tablets referencing Tegretol XR to comply with the March 2015 prod | 505(q) | 2019-07-26 | Denied | Axinn on behalf of Zydus Pharmaceuticals (USA) Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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