Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078057
Company: IMPAX LABS
Company: IMPAX LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | 37.5MG | CAPSULE, EXTENDED RELEASE; ORAL | None (Tentative Approval) | None | No | No |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | 75MG | CAPSULE, EXTENDED RELEASE; ORAL | None (Tentative Approval) | None | No | No |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | 150MG | CAPSULE, EXTENDED RELEASE; ORAL | None (Tentative Approval) | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/16/2007 | ORIG-1 | Tentative Approval |
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