Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.
PROGESTERONE | N020756 | WATSON LABS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Watson Laboratories, Inc. - Citizen Petition FDA-2013-P-0664 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.