Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.
CYCLOBENZAPRINE HYDROCHLORIDE | A090864 | PAR PHARM INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Teva Pharmaceuticals FDA-2016-P-1873 Teva Pharmaceuticals filed this petition under 21 USC 355(q) requesting that the FDA require any ANDA for cyclobenzaprine hydrochloride extended-release capsules referencing AMRIX to conduct a bioequivalence study demonstrating that the proposed generic product is bioequivalent to AMRIX when adminis | 505(q) | 2016-07-01 | Partially Denied | Teva Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.