Application 214127
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
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 |
|---|---|---|---|---|---|
| 67877-726 | Venlafaxine | Venlafaxine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-726 | Venlafaxine | Venlafaxine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-727 | Venlafaxine | Venlafaxine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-727 | Venlafaxine | Venlafaxine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-728 | Venlafaxine | Venlafaxine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-728 | Venlafaxine | Venlafaxine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-729 | Venlafaxine | Venlafaxine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-729 | Venlafaxine | Venlafaxine | Ascend Laboratories, LLC | ANDA | Current |