ANDA 205354, held by Monterey Pharms LLC. Methocarbamol.
As of Nov 15, 2026, ANDA 205354 (Methocarbamol), held by Monterey Pharms LLC, was first approved by FDA on Oct 27, 2016, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 27, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Methocarbamol1GM/10ML (100MG/ML) ยท solution;im-iv | Methocarbamol | Rx |
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
