AZACITIDINE | A204949 | PHARMOBEDIENT CONSULTING LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
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 |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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