Relieves discomfort associated with acute, painful musculoskeletal conditions. ANDA 209312, held by Granules. Methocarbamol.
As of Nov 14, 2026, ANDA 209312 (Methocarbamol), held by Granules, was first approved by FDA on May 7, 2018, with 2 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 |
|---|---|---|---|
| May 7, 2018 | Original application | Approved | None posted |
| Methocarbamol500MG · tablet;oral | Methocarbamol | Rx |
| Methocarbamol750MG · tablet;oral | Methocarbamol | Rx |
| Jul 14, 2020 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jul 14, 2020 | Supplement 5Labeling · Standard review | Approved | None posted |
| May 7, 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
