AZACITIDINE | N208216 | ACTAVIS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 2 - Draft Insert Labeling for Proposed Azacitidine for Injection -... FDA-2021-P-0910 · 6 docket documents 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 | Granted | Shilpa Pharma, 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the Federal Food, Drug, and Cosmetic Act on April 29, 2016 (NDA 208216), to permit substitution | Other | 2016-08-10 | Withdrawn | Actavis LLC |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.
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