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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204150
Company: ALEMBIC PHARMS LTD

Medication Guide

Summary Review

Products on NDA 204150

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DESVENLAFAXINE	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
DESVENLAFAXINE	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204150

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/04/2013	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Letter (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204150s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/204150Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/204150Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204150Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204150_desvenlafaxine_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204150Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/18/2023	SUPPL-20	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204150s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204150Orig1s020ltr.pdf
09/20/2021	SUPPL-18	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204150s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204150Orig1s018ltr.pdf
10/29/2019	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204150s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204150Orig1s010ltr.pdf
12/19/2017	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204150s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204150Orig1s007ltr.pdf
01/04/2017	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204150s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204150Orig1s005ltr.pdf
09/09/2016	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204150s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204150Orig1s004ltr.pdf
05/15/2015	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204150s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204150Orig1s003ltr.pdf
07/07/2014	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204150s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204150Orig1s001,s002ltr.pdf
07/07/2014	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204150s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204150Orig1s001,s002ltr.pdf

Labels for NDA 204150

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/18/2023	SUPPL-20	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204150s020lbl.pdf
08/18/2023	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204150s020lbl.pdf
09/20/2021	SUPPL-18	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204150s018lbl.pdf
09/20/2021	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204150s018lbl.pdf
10/29/2019	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204150s010lbl.pdf
12/19/2017	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204150s007lbl.pdf
01/04/2017	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204150s005lbl.pdf
09/09/2016	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204150s004lbl.pdf
05/15/2015	SUPPL-3	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204150s003lbl.pdf
05/15/2015	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204150s003lbl.pdf
07/07/2014	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204150s001s002lbl.pdf
07/07/2014	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204150s001s002lbl.pdf
03/04/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204150s000lbl.pdf

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