Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078789
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | 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 |
|---|---|---|---|---|---|---|---|
| 06/01/2011 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/078789Orig1s000.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/06/2023 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/06/2023 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/06/2023 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/06/2023 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/02/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/29/2014 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/29/2014 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |