ANDA 77088, held by Tp Anda Holdings. Baclofen.
As of Nov 13, 2026, ANDA 77088 (Baclofen), held by Tp Anda Holdings, was first approved by FDA on Oct 31, 2007, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 31, 2007 | Original application | Approved | None posted |
| May 27, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| Oct 31, 2007 | 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
