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.
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | A208359 | STRIDES PHARMA INTL
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Forest Laboratories LLC et al v. Amneal Pharmaceuticals LLC et al 12 patentsANDA 208328, 208359memantine hydrochloride extended-release and donepezil hydrochloride | D. Del. | 2015-08-27 | Terminated 2016-09-02 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.