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listed drugs and reference standards under section 505(j) to enable submission of abbrev | Other | 2020-12-15 | Withdrawn | Zydus Pharmaceuticals USA Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.