Relieves muscle spasm associated with acute, painful musculoskeletal conditions. NDA 21777, held by Teva Pharms Intl. Cyclobenzaprine Hydrochloride.
As of Nov 14, 2026, NDA 21777 (Amrix), held by Teva Pharms Intl, was first approved by FDA on Feb 1, 2007, with 8 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 |
|---|---|---|---|
| Feb 1, 2007 | Original applicationNew dosage form · Standard review | Approved |
| Amrix15MG · capsule, extended release;oral | Cyclobenzaprine Hydrochloride | RxReference drug |
| Amrix30MG · capsule, extended release;oral | Cyclobenzaprine Hydrochloride | RxReference drug |
| Apr 25, 2024 | Supplement 19Labeling · Standard review | Approved | |
| Apr 23, 2019 | Supplement 17Labeling · Standard review | Approved | |
| May 25, 2016 | Supplement 14Labeling · Standard review | Approved | |
| Mar 24, 2016 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jun 7, 2013 | Supplement 6Labeling · Standard review | Approved | |
| Jun 7, 2013 | Supplement 9Labeling · Standard review | Approved | |
| Apr 11, 2013 | Supplement 12Labeling | Approved | |
| Mar 24, 2008 | Supplement 3Labeling · Standard review | Approved | |
| Feb 1, 2007 | Original applicationNew dosage form · Standard review | 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
