Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022104
Company: OSMOTICA PHARM US
Company: OSMOTICA PHARM US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | Yes |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 225MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 05/20/2008 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Letter (PDF)
Review Summary Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022104s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022104_venlafaxine_hydrochloride_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022104s000_SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/18/2023 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022104s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022104Orig1s023ltr.pdf | |
| 09/20/2021 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022104s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204683Orig1s007; 022104Orig1s021ltr.pdf | |
| 12/19/2017 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022104s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204683Orig1s005,022104Orig1s016ltr.pdf | |
| 01/04/2017 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022104s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022104Orig1s015ltr.pdf | |
| 12/14/2016 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/24/2016 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/21/2016 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/18/2014 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022104s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022104Orig1s010ltr.pdf | |
| 12/11/2012 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022104s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022104Orig1s009ltr.pdf | |
| 05/02/2012 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022104s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022104s008ltr.pdf | |
| 07/31/2012 | SUPPL-7 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022104Orig1s007ltr.pdf |
| 01/30/2009 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022104s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022104s003ltr.pdf | |
| 02/27/2009 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022104s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022104s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/18/2023 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022104s023lbl.pdf | |
| 09/20/2021 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022104s021lbl.pdf | |
| 12/19/2017 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022104s016lbl.pdf | |
| 01/04/2017 | SUPPL-15 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022104s015lbl.pdf | |
| 01/04/2017 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022104s015lbl.pdf | |
| 07/18/2014 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022104s010lbl.pdf | |
| 12/11/2012 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022104s009lbl.pdf | |
| 05/02/2012 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022104s008lbl.pdf | |
| 02/27/2009 | SUPPL-2 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022104s002lbl.pdf | |
| 02/27/2009 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022104s002lbl.pdf | |
| 01/30/2009 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022104s003lbl.pdf |
VENLAFAXINE HYDROCHLORIDE
TABLET, 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 |
|---|---|---|---|---|---|---|---|---|
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214691 | AJANTA PHARMA LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214127 | ALKEM LABS LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214419 | ASCENT PHARMS INC |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022104 | OSMOTICA PHARM US |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091272 | SUN PHARM |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216044 | UNIQUE |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215622 | ZYDUS PHARMS |
TABLET, 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 |
|---|---|---|---|---|---|---|---|---|
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214691 | AJANTA PHARMA LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214127 | ALKEM LABS LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214419 | ASCENT PHARMS INC |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211323 | CADILA PHARMS LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213927 | DEXCEL |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022104 | OSMOTICA PHARM US |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091272 | SUN PHARM |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216044 | UNIQUE |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215622 | ZYDUS PHARMS |
TABLET, 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 |
|---|---|---|---|---|---|---|---|---|
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214691 | AJANTA PHARMA LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214127 | ALKEM LABS LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214609 | APPCO |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214419 | ASCENT PHARMS INC |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211323 | CADILA PHARMS LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209193 | DEXCEL |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205468 | NOSTRUM LABS INC |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022104 | OSMOTICA PHARM US |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091272 | SUN PHARM |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216044 | UNIQUE |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215622 | ZYDUS PHARMS |
TABLET, EXTENDED RELEASE;ORAL; EQ 225MG 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 225MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214691 | AJANTA PHARMA LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 225MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214127 | ALKEM LABS LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 225MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214609 | APPCO |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 225MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214419 | ASCENT PHARMS INC |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 225MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211323 | CADILA PHARMS LTD |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 225MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209193 | DEXCEL |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 225MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205468 | NOSTRUM LABS INC |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 225MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022104 | OSMOTICA PHARM US |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 225MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091272 | SUN PHARM |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 225MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216044 | UNIQUE |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 225MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215622 | ZYDUS PHARMS |