PROGESTERONE | N020701 | ABBVIE INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition Amendment from DDReg Pharma Inc. FDA-2024-P-0427 · 7 docket documents DDReg Pharma Inc. filed this amendment to suitability petition FDA-2024-P-0427 seeking approval to submit an ANDA for a progesterone pessary formulation at 400 mg strength in vaginal pessary dosage form, with Crinone 8% gel (90 mg vaginal gel, NDA N020701) as the reference listed drug, and requestin | Suitability | 2024-02-16 | Denied | — |
Watson Laboratories, Inc. - Citizen Petition FDA-2013-P-0664 · 4 docket documents Watson Laboratories, Inc. filed this citizen petition under sections 505 and 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refuse to approve any ANDA for a generic version of CRINONE (progesterone gel) 4% and 8% unless the applicant demonstrates bioequivalence through bo | 505(q) | 2013-06-18 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$27.92
per gm
Lowest NADAC/Unit
$16.84
per gm
Brand NDCs
2
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00023615108CRINONE 8% GEL | $27.92 | GM | Brand | — | 2026-01-02 |
| 00023615004CRINONE 4% GEL | $16.84 | GM | Brand | — | 2026-01-02 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.