ANDA 90864, held by Par Pharm Inc. Cyclobenzaprine Hydrochloride.
As of Nov 15, 2026, ANDA 90864 (Cyclobenzaprine Hydrochloride), held by Par Pharm Inc, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 26, 2013 | Original application | Tentative approval | None posted |
| Cyclobenzaprine Hydrochloride15MG · capsule, extended release; oral | Cyclobenzaprine Hydrochloride | None (tentative approval) |
| Cyclobenzaprine Hydrochloride30MG · capsule, extended release; oral | Cyclobenzaprine Hydrochloride | None (tentative approval) |
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
