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.
SODIUM OXYBATE | A203351 | OHM LABS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
JAZZ PHARMACEUTICALS, INC. et al v. SUN PHARMACEUTICAL INDUSTRIES LTD. et al 1 patentANDA 203351sodium oxybate | D.N.J. | 2015-11-23 | Terminated 2016-04-26 | — |
JAZZ PHARMACEUTICALS, INC. et al v. RANBAXY LABORATORIES LIMITED et al 1 patentANDA 203351sodium oxybate | D.N.J. | 2014-10-02 | Terminated 2015-04-21 | — |
JAZZ PHARMACEUTICALS, INC. v. RANBAXY LABORATORIES LIMITED et al 14 patentsANDA 203351sodium oxybate | D.N.J. | 2014-07-15 | Terminated 2015-04-22 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.