ANDA 84589, held by Nexgen Pharma Inc. Meprobamate.
As of Nov 14, 2026, ANDA 84589 (Meprobamate), held by Nexgen Pharma Inc, was first approved by FDA on Apr 17, 1975, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 17, 1975 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Meprobamate400MG ยท tablet;oral | Meprobamate | Discontinued |
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
