Not in the current Orange Book — This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.
PROGESTERONE | N020756 | WATSON LABS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
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.
No patent or exclusivity listings for this strength.