PROGESTERONE | A210965 | EUGIA PHARMA SPECIALITIES LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Daré Biosciences, Inc. FDA-2023-P-1574 · 4 docket documents 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 | Granted | Daré Biosciences, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$1.48
per ml
Lowest NADAC/Unit
$1.48
per ml
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 55150030610PROGESTERONE 500 MG/10 ML VIAL | $1.48 | ML | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.