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.
AMANTADINE HYDROCHLORIDE | N017118 | ENDO PHARMS
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Osmotica Pharmaceutical US LLC et al v. Adamas Pharmaceuticals, Inc. et al 14 patentsANDA 075060amantadine hydrochloride | D. Del. | 2018-02-16 | Terminated 2021-01-07 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Hyman, Phelps & McNamara, P. C. FDA-2016-P-2469 Hyman, Phelps & McNamara, P.C. petitioned the FDA under 21 C.F.R. § 314.122 and 314.161 and FDC Act sections 505(j) and 505(w) to determine whether SYMMETREL (amantadine hydrochloride) Syrup, 50 mg/5 mL, approved under NDA 016023 and NDA 017118 and held by Endo Pharmaceuticals, was voluntarily withd | Other | 2016-08-10 | Granted | Hyman, Phelps & McNamara, P. C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.