Application 215622
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 37.5MG BASE | No | No |
| 002 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 75MG BASE | No | No |
| 003 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 150MG BASE | No | No |
| 004 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 225MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70710-1348 | Venlafaxine | Venlafaxine | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 70710-1349 | Venlafaxine | Venlafaxine | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 70710-1350 | Venlafaxine | Venlafaxine | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 70710-1352 | Venlafaxine | Venlafaxine | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 70771-1649 | Venlafaxine | Venlafaxine | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1650 | Venlafaxine | Venlafaxine | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1651 | Venlafaxine | Venlafaxine | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1652 | Venlafaxine | Venlafaxine | Zydus Lifesciences Limited | ANDA | Current |