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.
HALOBETASOL PROPIONATE | A214285 | PERRIGO ISRAEL
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
BAUSCH HEALTH IRELAND LIMITED et al v. PADAGIS ISRAEL PHARMACEUTICALS LTD et al 2 patentsANDA 214285halobetasol propionate | D.N.J. | 2020-05-01 | Terminated 2022-12-01 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.