MESALAMINE | A203286 | ZYDUS PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Alembic Labs LLC (USA) FDA-2022-P-0929 Alembic Labs LLC submitted this citizen petition on May 27, 2022, requesting that the FDA designate the generic mesalamine delayed-release tablets 800 mg marketed by Zydus Pharmaceuticals USA Inc. under ANDA A203286 as an alternate Reference Listed Drug because the original RLD, ASACOL HD (mesalamin | 505(q) | 2022-05-27 | Denied | Alembic Labs LLC (USA) |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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