PROGESTERONE | N017362 | ACTAVIS LABORATORIES UT INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from DDReg Pharma Inc. FDA-2024-P-0427 · 7 docket documents DDReg Pharma Inc. filed this suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA Commissioner determine the reference listed drug for an ANDA of a progesterone-based pessary formulation that differs in dosage form and strength from | Suitability | 2024-01-23 | Denied | DDReg Pharma Inc. |
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. |
Duramed Pharmaceuticals, Inc. - Citizen Petition FDA-2001-P-0030 · 8 docket documents Duramed Pharmaceuticals, Inc. submitted this petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA permit an Abbreviated New Drug Application for 100 mg and 200 mg progesterone tablet dosage forms bioequivalent to Prometrium Capsules, citing advantag | Other | 2010-03-11 | Granted | — |
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 |
|---|---|---|---|---|---|
| 00591312879PROGESTERONE 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.