Relieves discomfort associated with acute, painful musculoskeletal conditions. ANDA 86988, held by Prinston Inc. Methocarbamol.
As of Nov 14, 2026, ANDA 86988 (Methocarbamol), held by Prinston Inc, was first approved by FDA on Oct 29, 1979, with 7 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 |
|---|---|---|---|
| Oct 29, 1979 | Original application | Approved | None posted |
| Methocarbamol750MG · tablet;oral | Methocarbamol | Rx |
| Methocarbamol500MG · tablet;oral | Methocarbamol | Rx |
| Apr 8, 2025 | Supplement 15Labeling · Standard review | Approved | None posted |
| Sep 28, 2012 | Supplement 9Manufacturing | Approved | None posted |
| Nov 8, 1988 | Supplement 5Manufacturing | Approved | None posted |
| Nov 8, 1988 | Supplement 6Manufacturing | Approved | None posted |
| Nov 8, 1988 | Supplement 7Manufacturing | Approved | None posted |
| Jun 19, 1986 | Supplement 3Manufacturing | Approved | None posted |
| Jun 9, 1986 | Supplement 4Manufacturing | Approved | None posted |
| Oct 29, 1979 | 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
