Relieves muscle spasm associated with acute, painful musculoskeletal conditions. ANDA 207314, held by Macleods Pharms. Cyclobenzaprine Hydrochloride.
As of Nov 15, 2026, ANDA 207314 (Cyclobenzaprine Hydrochloride), held by Macleods Pharms, was first approved by FDA on Jul 22, 2024, with 0 approved supplements and 0 published complete response letters.
Cyclobenzaprine hydrochloride extended-release capsules 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, and limitation of motion.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 22, 2024 | Original application | Approved | None posted |
| Cyclobenzaprine Hydrochloride15MG · capsule, extended release;oral | Cyclobenzaprine Hydrochloride | Rx |
| Cyclobenzaprine Hydrochloride30MG · capsule, extended release;oral | Cyclobenzaprine Hydrochloride | Rx |
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
