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.
CARBIDOPA, LEVODOPA | A219989 | SANDOZ INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
AMNEAL PHARMACEUTICALS LLC et al v. SANDOZ INC 25 patentsANDA 219989carbidopa and levodopa | D.N.J. | 2025-11-12 | Active | — |
AMNEAL PHARMACEUTICALS LLC et al v. SANDOZ INC. 19 patentsANDA 219989carbidopa and levodopa | D.N.J. | 2025-06-20 | Active | — |
AMNEAL PHARMACEUTICALS LLC et al v. SANDOZ INC. 12 patentsANDA 219989carbidopa and levodopa | D.N.J. | 2025-01-07 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.