ANDA 209592, held by Pharmobedient. Baclofen.
As of Nov 14, 2026, ANDA 209592 (Baclofen), held by Pharmobedient, was first approved by FDA on Mar 21, 2018, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 21, 2018 | Original application | Approved |
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
