ANDA 209594, held by Pharmobedient. Baclofen.
As of Nov 13, 2026, ANDA 209594 (Baclofen), held by Pharmobedient, was first approved by FDA on Mar 6, 2018, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 6, 2018 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Baclofen1MG/ML · injectable;intrathecal | Baclofen | Discontinued |
| Mar 3, 2025 | Supplement 4Labeling · Standard review | Approved | None posted |
| Oct 22, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Oct 22, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| Mar 6, 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
