AZACITIDINE | A207518 | SHILPA MEDICARE LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability petition from Shilpa Pharma, Inc. FDA-2021-P-0910 Shilpa Pharma Inc. submitted this petition on August 14, 2021, pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA declare Azacitidine for Injection in 50 mg/vial and 150 mg/vial strengths suitable for submission as a prior approval supplement to app | Suitability | 2021-08-16 | Open | Shilpa Pharma |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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