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.
DICLOFENAC SODIUM | A207238 | ACTAVIS LABS UT INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
HORIZON PHARMA USA, INC. et al v. ACTAVIS LABORATORIES UT, INC. et al 4 patentsANDA 207238diclofenac sodium topical solution 2% w/w | D.N.J. | 2016-08-18 | Terminated 2017-08-09 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.