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.
DEXAMETHASONE | A088316 | HIKMA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Zydus Pharmaceuticals USA Inc FDA-2020-P-2299 Zydus Pharmaceuticals USA Inc. submitted this citizen petition on November 30, 2020, requesting that the FDA designate dexamethasone tablets 1 mg and 2 mg held by Hikma Pharmaceuticals USA Inc. as both reference listed drugs and reference standards under section 505(j) to enable submission of abbrev | Other | 2020-12-15 | Withdrawn | Zydus Pharmaceuticals USA Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.