Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076565
Company: TEVA
Company: TEVA
| 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 | Prescription | AB | No | No |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 06/28/2010 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/076565s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/076565Orig1s000.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/12/2024 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/24/2023 | SUPPL-22 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 03/24/2023 | SUPPL-21 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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| 11/03/2020 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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| 11/03/2020 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/03/2020 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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| 11/03/2020 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/03/2020 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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| 10/01/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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| 09/19/2014 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/19/2014 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/19/2014 | SUPPL-5 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/19/2014 | SUPPL-4 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/19/2012 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
VENLAFAXINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL; EQ 37.5MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| EFFEXOR XR | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020699 | UPJOHN |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 217767 | ALEMBIC |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212277 | ANNORA PHARMA |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200834 | AUROBINDO PHARMA LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078421 | DR REDDYS LABS LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 217390 | GRANULES |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203332 | INVENTIA HLTHCARE |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204889 | MACLEODS PHARMS LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201272 | MEDICAP LABS |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091123 | ORBION PHARMS |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078865 | SCIEGEN PHARMS |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076565 | TEVA |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214654 | YICHANG HUMANWELL |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090174 | ZYDUS PHARMS USA INC |
CAPSULE, EXTENDED RELEASE;ORAL; EQ 75MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| EFFEXOR XR | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020699 | UPJOHN |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 217767 | ALEMBIC |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212277 | ANNORA PHARMA |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200834 | AUROBINDO PHARMA LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078421 | DR REDDYS LABS LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 217390 | GRANULES |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203332 | INVENTIA HLTHCARE |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204889 | MACLEODS PHARMS LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201272 | MEDICAP LABS |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091123 | ORBION PHARMS |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078865 | SCIEGEN PHARMS |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076565 | TEVA |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214654 | YICHANG HUMANWELL |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090174 | ZYDUS PHARMS USA INC |
CAPSULE, EXTENDED RELEASE;ORAL; EQ 150MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| EFFEXOR XR | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020699 | UPJOHN |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 217767 | ALEMBIC |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212277 | ANNORA PHARMA |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200834 | AUROBINDO PHARMA LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078421 | DR REDDYS LABS LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 217390 | GRANULES |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203332 | INVENTIA HLTHCARE |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204889 | MACLEODS PHARMS LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201272 | MEDICAP LABS |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091123 | ORBION PHARMS |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078865 | SCIEGEN PHARMS |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076565 | TEVA |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214654 | YICHANG HUMANWELL |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090174 | ZYDUS PHARMS USA INC |