CYCLOBENZAPRINE HYDROCHLORIDE | A206703 | APOTEX INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Adare Pharmaceuticals, Inc. et al v. Apotex Inc. et al 2 patentsANDA 206703cyclobenzaprine HCl | D. Del. | 2014-08-11 | Terminated 2018-09-11 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| 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.