Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021992
Company: PF PRISM CV
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRISTIQ DESVENLAFAXINE SUCCINATE EQ 50MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes Yes
PRISTIQ DESVENLAFAXINE SUCCINATE EQ 100MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes Yes
PRISTIQ DESVENLAFAXINE SUCCINATE EQ 25MG 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
02/29/2008 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021992lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021992s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021992s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/19/2017 SUPPL-46 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021992s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021992Orig1s046ltr.pdf
01/04/2017 SUPPL-44 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021992s044lbl.pdf
08/26/2016 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021992s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021992Orig1s043ltr.pdf
02/06/2018 SUPPL-42 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021992s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021992Orig1s042ltr.pdf
03/16/2016 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

07/17/2014 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021992s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021992Orig1s040ltr.pdf
08/20/2014 SUPPL-39 Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021992Orig1s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021992Orig1s039ltr.pdf
12/23/2013 SUPPL-37 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021992s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021992Orig1s037ltr.pdf
02/14/2013 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021992s033s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021992Orig1s033,s036ltr.pdf
04/19/2013 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

12/07/2012 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021992s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021992Orig1s034ltr.pdf
02/14/2013 SUPPL-33 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021992s033s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021992Orig1s033,s036ltr.pdf
12/10/2013 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021992s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021992Orig1s031ltr.pdf
03/07/2012 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021992s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021992s030ltr.pdf
04/11/2011 SUPPL-22 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021992s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021992s022ltr.pdf
03/04/2011 SUPPL-21 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021992s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021992s021ltr.pdf
01/31/2011 SUPPL-20 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021992s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021992s020ltr.pdf
12/29/2010 SUPPL-19 Labeling, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021992s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021992s019ltr.pdf
09/08/2010 SUPPL-17 Labeling, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021992s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021992s017ltr.pdf
07/09/2010 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021992s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021992s015ltr.pdf
10/18/2010 SUPPL-13 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021992s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021992s013ltr.pdf
02/16/2010 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021992s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021992s011ltr.pdf
11/09/2009 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021992s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021992s009ltr.pdf
11/09/2009 SUPPL-8 Labeling-Medication Guide Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021992s008ltr.pdf
08/31/2009 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021992s001s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021992s001,006,007ltr.pdf
08/31/2009 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021992s001s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021992s001,006,007ltr.pdf
04/23/2009 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021992s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021992s005ltr.pdf
01/30/2009 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021992s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021992s004ltr.pdf
08/31/2009 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021992s001s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021992s001,006,007ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/06/2018 SUPPL-42 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021992s042lbl.pdf
12/19/2017 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021992s046lbl.pdf
01/04/2017 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021992s044lbl.pdf
08/26/2016 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021992s043lbl.pdf
08/20/2014 SUPPL-39 Type 1 - New Molecular Entity Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021992Orig1s039lbl.pdf
07/17/2014 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021992s040lbl.pdf
12/23/2013 SUPPL-37 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021992s037lbl.pdf
12/23/2013 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021992s037lbl.pdf
12/10/2013 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021992s031lbl.pdf
02/14/2013 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021992s033s036lbl.pdf
02/14/2013 SUPPL-33 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021992s033s036lbl.pdf
12/07/2012 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021992s034lbl.pdf
03/07/2012 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021992s030lbl.pdf
04/11/2011 SUPPL-22 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021992s022lbl.pdf
03/04/2011 SUPPL-21 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021992s021lbl.pdf
01/31/2011 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021992s020lbl.pdf
01/31/2011 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021992s020lbl.pdf
12/29/2010 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021992s019lbl.pdf
12/29/2010 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021992s019lbl.pdf
10/18/2010 SUPPL-13 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021992s013lbl.pdf
09/08/2010 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021992s017lbl.pdf
09/08/2010 SUPPL-17 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021992s017lbl.pdf
07/09/2010 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021992s015lbl.pdf
02/16/2010 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021992s011lbl.pdf
11/09/2009 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021992s009lbl.pdf
08/31/2009 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021992s001s006s007lbl.pdf
08/31/2009 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021992s001s006s007lbl.pdf
08/31/2009 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021992s001s006s007lbl.pdf
04/23/2009 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021992s005lbl.pdf
01/30/2009 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021992s004lbl.pdf
02/29/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021992lbl.pdf

PRISTIQ

TABLET, EXTENDED RELEASE;ORAL; EQ 50MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE EQ 50MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204065 ACTAVIS LABS FL
DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE EQ 50MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204003 ALEMBIC PHARMS LTD
DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE EQ 50MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204028 CASI PHARMS INC
DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE EQ 50MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204805 INTELLIPHARMACEUTICS
DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE EQ 50MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204172 LUPIN LTD
DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE EQ 50MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204095 MYLAN
DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE EQ 50MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204082 WEST-WARD PHARMS INT
DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE EQ 50MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204020 ZYDUS PHARMS
PRISTIQ DESVENLAFAXINE SUCCINATE EQ 50MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021992 PF PRISM CV

TABLET, EXTENDED RELEASE;ORAL; EQ 100MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE EQ 100MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204065 ACTAVIS LABS FL
DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE EQ 100MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204003 ALEMBIC PHARMS LTD
DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE EQ 100MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204028 CASI PHARMS INC
DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE EQ 100MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204805 INTELLIPHARMACEUTICS
DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE EQ 100MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204172 LUPIN LTD
DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE EQ 100MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204083 WEST-WARD PHARMS INT
DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE EQ 100MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204020 ZYDUS PHARMS
PRISTIQ DESVENLAFAXINE SUCCINATE EQ 100MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021992 PF PRISM CV

TABLET, EXTENDED RELEASE;ORAL; EQ 25MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE EQ 25MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204065 ACTAVIS LABS FL
DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE EQ 25MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204003 ALEMBIC PHARMS LTD
DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE EQ 25MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204082 WEST-WARD PHARMS INT
PRISTIQ DESVENLAFAXINE SUCCINATE EQ 25MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021992 PF PRISM CV

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