ANDA 214114, held by Regcon Holdings. Baclofen.
As of Nov 13, 2026, ANDA 214114 (Baclofen), held by Regcon Holdings, was first approved by FDA on Jul 16, 2021, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 16, 2021 | Original application | Approved | None posted |
| Sep 19, 2023 | Supplement 2Manufacturing | Approved | None posted |
| Jul 16, 2021 | Original application | Approved | None posted |
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
