Relieves flexor spasms and concomitant pain, clonus, and muscular rigidity. ANDA 78504, held by Northstar Hlthcare. Baclofen.
As of Nov 13, 2026, ANDA 78504 (Baclofen), held by Northstar Hlthcare, was first approved by FDA on Sep 18, 2009, with 4 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 |
|---|---|---|---|
| Sep 18, 2009 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Baclofen10MG · tablet;oral | Baclofen | Rx |
| Apr 15, 2015 | Supplement 4Labeling | Approved | None posted |
| Apr 15, 2015 | Supplement 5Labeling · Standard review | Approved | None posted |
| Dec 28, 2011 | Supplement 2Labeling | Approved | None posted |
| Mar 25, 2010 | Supplement 1Labeling | Approved | None posted |
| Sep 18, 2009 | 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
