Relieves discomfort associated with acute, painful musculoskeletal conditions. ANDA 213967, held by Aurobindo Pharma Ltd. Methocarbamol.
As of Nov 14, 2026, ANDA 213967 (Methocarbamol), held by Aurobindo Pharma Ltd, was first approved by FDA on Aug 12, 2020, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Methocarbamol tablets are 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 methocarbamol 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 |
|---|---|---|---|
| Aug 12, 2020 | Original application | Approved | None posted |
| Methocarbamol750MG · tablet;oral | Methocarbamol | Rx |
| Methocarbamol500MG · tablet;oral | Methocarbamol | Rx |
| Feb 9, 2023 | Supplement 2Manufacturing | Approved | None posted |
| Aug 12, 2020 | 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
