Application 091123
- Type
- ANDA
- Sponsor
- ORCHID HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 37.5MG BASE | No | No |
| 002 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 75MG BASE | No | No |
| 003 | VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 150MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68820-105 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Orchid Healthcare (a division of Orchid Chemicals & Pharmaceuticals Ltd.) | ANDA | Current |
| 68820-106 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Orchid Healthcare (a division of Orchid Chemicals & Pharmaceuticals Ltd.) | ANDA | Current |
| 68820-107 | Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | Orchid Healthcare (a division of Orchid Chemicals & Pharmaceuticals Ltd.) | ANDA | Current |