ANDA 77862, held by Sun Pharm Inds Inc. Baclofen.
As of Nov 13, 2026, ANDA 77862 (Baclofen), held by Sun Pharm Inds Inc, was first approved by FDA on Aug 14, 2006, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 14, 2006 | 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
