Relieves flexor spasms and concomitant pain, clonus, and muscular rigidity. ANDA 209102, held by Rubicon Research. Baclofen.
As of Nov 14, 2026, ANDA 209102 (Baclofen), held by Rubicon Research, was first approved by FDA on Nov 28, 2017, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Baclofen tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 28, 2017 | Original application | Approved |
| Feb 5, 2024 | Supplement 15Manufacturing | Approved | None posted |
| Sep 12, 2023 | Supplement 8Labeling · Standard review | Approved | None posted |
| Nov 28, 2017 | Original application | Approved |
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
