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.
CYCLOSPORINE | N021023 | ALLERGAN
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Allergan, Inc. v. Actavis plc et al 5 patentsANDA 203463cyclosporine ophthalmic emulsion 0.05% | E.D. Tex. | 2014-05-22 | Terminated 2015-03-19 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.