ANDA 90334, held by Somerset Theraps LLC. Baclofen.
As of Nov 13, 2026, ANDA 90334 (Baclofen), held by Somerset Theraps LLC, was first approved by FDA on Feb 18, 2010, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 18, 2010 | Original application | Approved | None posted |
| May 23, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Feb 18, 2010 | 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
