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.
ACETYLCYSTEINE | A203624 | RISING
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC et al 1 patentANDA 203624N-acetylcysteine (acetylcysteine) | N.D. Ill. | 2012-05-17 | Terminated 2015-11-17 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.