Relieves discomfort associated with acute, painful musculoskeletal conditions. ANDA 212623, held by Pharmazone. Methocarbamol.
As of Nov 14, 2026, ANDA 212623 (Methocarbamol), held by Pharmazone, was first approved by FDA on Apr 30, 2021, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Methocarbamol Tablets, USP 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 |
|---|---|---|---|
| Apr 30, 2021 | 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
