PROGESTERONE | N017362 | ACTAVIS LABORATORIES UT INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Daré Biosciences, Inc. FDA-2023-P-1574 Daré Bioscience, Inc. filed a citizen petition under section 505(w) requesting that the FDA determine that the discontinued Progesterone Injection USP 50 mg/mL (NDA 017362) from Actavis Lab UT Inc was not discontinued due to safety or efficacy reasons. This determination is necessary to allow Daré t | 505(q) | 2023-04-21 | Denied | Daré Biosciences |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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