| Application # | Type | Sponsor | Notes | Product # | Drug Name | Form | Strength | Active Ingredient | Approval Date | Marketing Status | Reference Standard |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 208653 | NDA | ZEVRA THERAP | 001 | APADAZ | TABLET;ORAL | 325MG;EQ 6.12MG BASE | ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE | 2018-02-23 | Discontinued | No | |
| 002 | APADAZ | TABLET;ORAL | 325MG;EQ 4.08MG BASE | ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE | 2018-02-23 | Discontinued | No | ||||
| 003 | APADAZ | TABLET;ORAL | 325MG;EQ 8.16MG BASE | ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE | 2018-02-23 | Discontinued | No |