Relieves muscle spasm associated with acute, painful musculoskeletal conditions. ANDA 91281, held by Twi Pharms Inc. Cyclobenzaprine Hydrochloride.
As of Nov 15, 2026, ANDA 91281 (Cyclobenzaprine Hydrochloride), held by Twi Pharms Inc, was first approved by FDA on Jan 31, 2013, with 4 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 |
|---|---|---|---|
| Jan 31, 2013 | Original application | Approved | None posted |
| Cyclobenzaprine Hydrochloride15MG · capsule, extended release;oral | Cyclobenzaprine Hydrochloride | Rx |
| Cyclobenzaprine Hydrochloride30MG · capsule, extended release;oral | Cyclobenzaprine Hydrochloride | Rx |
| Dec 17, 2024 | Supplement 16Labeling · Standard review | Approved | None posted |
| Oct 13, 2023 | Supplement 10Labeling · Standard review | Approved | None posted |
| Mar 13, 2018 | Supplement 6Bioequivalence | Approved | None posted |
| Nov 6, 2014 | Supplement 2Manufacturing | Approved | None posted |
| Jan 31, 2013 | 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
