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.
VASOPRESSIN | A212945 | AMNEAL EU LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
PAR PHARMACEUTICAL, INC. et al v. AMNEAL EU, LIMITED et al 1 patentANDA 212944, 212945vasopressin | D.N.J. | 2020-12-07 | Terminated 2022-02-10 | — |
Par Pharmaceutical, Inc. et al v. Amneal Pharmaceuticals Company GmbH et al 2 patentsANDA 212944, 212945vasopressin | D. Del. | 2019-04-18 | Terminated 2022-02-09 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.