Not in the current Orange Book— This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.
DEXAMETHASONE | A088316 | HIKMA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Zydus Pharmaceuticals USA Inc FDA-2020-P-2299 · 4 docket documents 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 | WithdrawnUnverified summary | Zydus Pharmaceuticals USA Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.