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 | A208068 | PADDOCK LABS
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Horizon Pharma Ireland Limited et al v. Paddock Laboratories LLC et al 6 patentsANDA 208068diclofenac sodium topical solution | D. Del. | 2015-01-14 | Terminated 2015-04-29 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.