Relieves discomfort associated with acute, painful musculoskeletal conditions. ANDA 205404, held by Sagent Pharms Inc. Methocarbamol.
As of Nov 14, 2026, ANDA 205404 (Methocarbamol), held by Sagent Pharms Inc, was first approved by FDA on Jul 18, 2017, 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 |
|---|---|---|---|
| Jul 18, 2017 | 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
