ANDA 84471, held by Puracap Pharm. Methocarbamol.
As of Nov 14, 2026, ANDA 84471 (Methocarbamol), held by Puracap Pharm, was first approved by FDA on Feb 25, 1975, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 25, 1975 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Methocarbamol750MG ยท tablet;oral | Methocarbamol | Discontinued |
| Jun 30, 1989 | Supplement 27Bioequivalence | Approved | None posted |
| Jun 10, 1988 | Supplement 21Labeling | Approved | None posted |
| Feb 18, 1983 | Supplement 18Manufacturing | Approved | None posted |
| Sep 25, 1981 | Supplement 17Manufacturing | Approved | None posted |
| Feb 25, 1975 | 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
