Relieves discomfort associated with acute, painful musculoskeletal conditions. ANDA 209331, held by Fresenius Kabi USA. Methocarbamol.
As of Nov 14, 2026, ANDA 209331 (Methocarbamol), held by Fresenius Kabi USA, was first approved by FDA on Apr 17, 2018, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE: The injection form of methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 17, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Methocarbamol1GM/10ML (100MG/ML) · 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
