PROGESTERONE | N019781 | ACERTIS PHARMACEUTICALS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Amendment to Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-2353 Hyman, Phelps & McNamara, P.C. filed this amended suitability petition on behalf of a client pursuant to Section 505(j)(2)(C) of the FDC Act requesting that FDA declare Progesterone Tablets, 150 mg, suitable for submission in an ANDA, with the reference listed drug being Acertis Pharmaceuticals' PRO | Suitability | 2026-04-06 | Open | Hyman, Phelps & McNamara, P.C. |
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-2353 Hyman, Phelps & McNamara, P.C., filed this Suitability Petition on behalf of a client pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act, requesting that the FDA declare Progesterone Tablets in 150 mg and 300 mg strengths suitable for submission as an Abbreviated New Drug Ap | Suitability | 2026-03-06 | Open | Hyman, Phelps & McNamara, P.C. |
Duramed Pharmaceuticals, Inc. - Citizen Petition FDA-2001-P-0030 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
$30.39
per ea
Lowest NADAC/Unit
$15.94
per ea
Brand NDCs
2
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 72989037330PROMETRIUM 200 MG CAPSULE | $30.39 | EA | Brand | $0.4108 | 2026-10-21 |
| 72989037230PROMETRIUM 100 MG CAPSULE | $15.94 | EA | Brand | $0.2329 | 2026-10-21 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.