ANDA 206952, held by Actavis Labs Fl Inc. Hydrocodone Bitartrate.
As of Nov 15, 2026, ANDA 206952 (Hydrocodone Bitartrate), held by Actavis Labs Fl Inc, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 5, 2017 | Original application | Tentative approval | None posted |
| Hydrocodone Bitartrate10MG · capsule, extended release; oral | Hydrocodone Bitartrate | None (tentative approval) |
| Hydrocodone Bitartrate40MG · capsule, extended release;oral | Hydrocodone Bitartrate | None (tentative approval) |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
