Relieves discomfort associated with acute, painful musculoskeletal conditions. ANDA 206128, held by Eugia Pharma. Methocarbamol.
As of Nov 14, 2026, ANDA 206128 (Methocarbamol), held by Eugia Pharma, was first approved by FDA on May 27, 2016, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE The injectable 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 |
|---|---|---|---|
| May 27, 2016 | Original application | Approved |
| 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
