Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022104
Company: OSMOTICA PHARM
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
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-Package Insert, Labeling-Medication Guide 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-Package Insert, Labeling-Container/Carton Labels 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
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022104s015lbl.pdf
01/04/2017 SUPPL-15 Labeling-Medication Guide 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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022104s002lbl.pdf
02/27/2009 SUPPL-2 Labeling-Container/Carton Labels 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 Yes AB 022104 OSMOTICA PHARM
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091272 SUN PHARM

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 211323 CADILA PHARMS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022104 OSMOTICA PHARM
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091272 SUN PHARM

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 211323 CADILA PHARMS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209193 DEXCEL PHARMA
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
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091272 SUN PHARM

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 211323 CADILA PHARMS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 225MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209193 DEXCEL PHARMA
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
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 225MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091272 SUN PHARM

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