Not in the current Orange Book— This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.
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 · 6 docket documents 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 | GrantedNo FDA response document on docket | Hyman, Phelps & McNamara, P. C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.