Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079098
Company: AMNEAL PHARMS
Company: AMNEAL PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 05/11/2010 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/18/2023 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/11/2023 | SUPPL-16 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/20/2021 | SUPPL-13 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/10/2020 | SUPPL-8 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/04/2017 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/17/2014 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/11/2014 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/24/2012 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
VENLAFAXINE HYDROCHLORIDE
TABLET;ORAL; EQ 25MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 078932 | ALEMBIC PHARMS LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 079098 | AMNEAL PHARMS |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 090555 | AUROBINDO PHARMA |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 206250 | CADILA PHARMS LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 078301 | DR REDDYS LABS LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 078554 | HERITAGE PHARMS |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 078627 | SUN PHARM INDS INC |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 076690 | TEVA |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 202036 | YAOPHARMA CO LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 077653 | ZYDUS PHARMS USA |
TABLET;ORAL; EQ 37.5MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET;ORAL | Prescription | No | AB | 078932 | ALEMBIC PHARMS LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET;ORAL | Prescription | No | AB | 079098 | AMNEAL PHARMS |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET;ORAL | Prescription | No | AB | 090555 | AUROBINDO PHARMA |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET;ORAL | Prescription | No | AB | 206250 | CADILA PHARMS LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET;ORAL | Prescription | No | AB | 078301 | DR REDDYS LABS LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET;ORAL | Prescription | No | AB | 078554 | HERITAGE PHARMS |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET;ORAL | Prescription | No | AB | 078627 | SUN PHARM INDS INC |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET;ORAL | Prescription | No | AB | 076690 | TEVA |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET;ORAL | Prescription | No | AB | 202036 | YAOPHARMA CO LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET;ORAL | Prescription | No | AB | 077653 | ZYDUS PHARMS USA |
TABLET;ORAL; EQ 50MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 078932 | ALEMBIC PHARMS LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 079098 | AMNEAL PHARMS |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 090555 | AUROBINDO PHARMA |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 206250 | CADILA PHARMS LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 078301 | DR REDDYS LABS LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 078554 | HERITAGE PHARMS |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 078627 | SUN PHARM INDS INC |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 076690 | TEVA |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 202036 | YAOPHARMA CO LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 077653 | ZYDUS PHARMS USA |
TABLET;ORAL; EQ 75MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 078932 | ALEMBIC PHARMS LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 079098 | AMNEAL PHARMS |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 090555 | AUROBINDO PHARMA |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 206250 | CADILA PHARMS LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 078301 | DR REDDYS LABS LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 078554 | HERITAGE PHARMS |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 078627 | SUN PHARM INDS INC |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 076690 | TEVA |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 202036 | YAOPHARMA CO LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 077653 | ZYDUS PHARMS USA |
TABLET;ORAL; EQ 100MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 078932 | ALEMBIC PHARMS LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 079098 | AMNEAL PHARMS |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 090555 | AUROBINDO PHARMA |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 206250 | CADILA PHARMS LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 078301 | DR REDDYS LABS LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 078554 | HERITAGE PHARMS |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 078627 | SUN PHARM INDS INC |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 076690 | TEVA |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 202036 | YAOPHARMA CO LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 077653 | ZYDUS PHARMS USA |