CYCLOBENZAPRINE HYDROCHLORIDE | A091281 | TWI PHARMACEUTICALS 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.
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