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.
NORETHINDRONE ACETATE;ETHINYL ESTRADIOL;FERROUS FUMARATE | A203113 | LUPIN LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
WARNER CHILCOTT COMPANY, LLC v. LUPIN LTD. et al 2 patentsANDA 203113norethindrone acetate and ethinyl estradiol | D.N.J. | 2011-09-01 | Terminated 2014-01-17 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.