Relieves discomfort associated with acute, painful musculoskeletal conditions. ANDA 211504, held by Gland. Methocarbamol.
As of Nov 14, 2026, ANDA 211504 (Methocarbamol), held by Gland, was first approved by FDA on Oct 26, 2018, with 1 approved supplement 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 |
|---|---|---|---|
| Oct 26, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Methocarbamol1GM/10ML (100MG/ML) · solution;im-iv | Methocarbamol | Rx |
| Aug 4, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Oct 26, 2018 | 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
