AMIODARONE HYDROCHLORIDE | A076217 | MYLAN INSTITUTIONAL LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Bioniche Pharma Group Limited FDA-2002-P-0397 Bioniche Pharma (Canada) Ltd. filed a supplemental ANDA suitability petition under 21 CFR 314.93 requesting permission to file a supplemental ANDA for Amiodarone Hydrochloride Injection, 50 mg/mL in a 9 mL vial (450 mg total content) based on approved ANDA 76-217, differing from the reference listed | Other | 2023-03-30 | Granted | Bioniche Pharma Group Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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