AZACITIDINE | N050794 | BRISTOL-MYERS SQUIBB CO
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition Approval Letter from FDA CDER to Shilpa Pharma, Inc. FDA-2021-P-0910 Shilpa Pharma, Inc. filed a petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting permission to submit an Abbreviated New Drug Application for Azacitidine for Injection in 50 mg/vial and 150 mg/vial strengths, with Vidaza (Azacitidine) for Injection 100 mg/vial a | Suitability | 2023-09-06 | Open | — |
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 |
Attachment 3 - Labeling of the approved product, Azacitidine for Injection -1... FDA-2021-P-0910 Shilpa Pharma, Inc. filed a petition regarding the labeling of Azacitidine for Injection 100 mg/vial, an approved product marketed by Celgene Corporation, as part of a suitability petition for manufacturing or distribution purposes. | Suitability | 2021-08-16 | Open | Shilpa Pharma |
Attachment 2 - Draft Insert Labeling for Proposed Azacitidine for Injection -... FDA-2021-P-0910 Shilpa Pharma, Inc. submitted a suitability petition regarding proposed azacitidine for injection in 50 mg/vial and 150 mg/vial formulations, requesting FDA review of draft insert labeling for these dosage strengths. | Suitability | 2021-08-16 | Open | Shilpa Pharma |
Citizen Petition from Mylan Pharmaceuticals, Inc FDA-2017-P-4145 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 |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Code | Date | Status |
|---|---|---|
| ODE-399 | May 20, 2029 | Active |