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.
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | A207113 | ACTAVIS LABS FL INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
MALLINCKRODT LLC et al v. WATSON LABORATORIES, INC.- FLORIDA et al 7 patentsANDA 207113oxycodone hydrochloride and acetaminophen | D.N.J. | 2015-06-05 | Terminated 2017-07-13 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.