AZACITIDINE | N050794 | BRISTOL-MYERS SQUIBB CO
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability petition from Shilpa Pharma, Inc. FDA-2021-P-0910 · 6 docket documents 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 | Granted | Shilpa Pharma, Inc. |
Citizen Petition from Mylan Pharmaceuticals, Inc FDA-2017-P-4145 · 5 docket documents Mylan Pharmaceuticals Inc. filed this citizen petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Azacitidine for Injection, 50 mg/vial suitable for submission as an ANDA, with Vidaza (Azacitidine) for Injection, 100 mg/vial as the ref | Other | 2017-07-11 | Open | Mylan Pharmaceuticals, Inc |
Citizen Petition from Actavis LLC FDA-2016-P-2467 · 3 docket documents Actavis LLC filed a citizen petition requesting that the FDA assign a therapeutic equivalence code of AP for Actavis's Azacitidine for Injection 100 mg/vial, which was approved under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act on April 29, 2016 (NDA 208216), to permit substitution | Other | 2016-08-10 | Withdrawn | Actavis LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Code | Date | Status |
|---|---|---|
| ODE-399 | May 20, 2029 | Active |