Relieves discomfort associated with acute, painful musculoskeletal conditions. ANDA 208507, held by Regcon Holdings. Methocarbamol.
As of Nov 14, 2026, ANDA 208507 (Methocarbamol), held by Regcon Holdings, was first approved by FDA on Jul 21, 2017, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Methocarbamol Tablets USP, 500 mg and 750 mg 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 |
|---|---|---|---|
| Jul 21, 2017 | Original application | Approved | None posted |
| Methocarbamol500MG · tablet;oral | Methocarbamol | Rx |
| Methocarbamol750MG · tablet;oral | 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
