Relieves muscle spasm associated with acute, painful musculoskeletal conditions. ANDA 78643, held by Aurobindo Pharma. Cyclobenzaprine Hydrochloride.
As of Nov 15, 2026, ANDA 78643 (Cyclobenzaprine Hydrochloride), held by Aurobindo Pharma, was first approved by FDA on Sep 26, 2008, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 26, 2008 | Original application | Approved | None posted |
| Cyclobenzaprine Hydrochloride5MG · tablet;oral | Cyclobenzaprine Hydrochloride | Rx |
| Cyclobenzaprine Hydrochloride10MG · tablet;oral | Cyclobenzaprine Hydrochloride | Rx |
| Apr 11, 2013 | Supplement 4Labeling · Standard review | Approved | None posted |
| Sep 26, 2008 | 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
