Relieves discomfort associated with acute, painful musculoskeletal conditions. ANDA 207522, held by Somerset Theraps LLC. Methocarbamol.
As of Nov 14, 2026, ANDA 207522 (Methocarbamol), held by Somerset Theraps LLC, was first approved by FDA on Jul 31, 2017, with 2 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 |
|---|---|---|---|
| Jul 31, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Methocarbamol1GM/10ML (100MG/ML) · solution;im-iv | Methocarbamol | Rx |
| Jul 8, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jul 8, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jul 31, 2017 | 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
