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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205583
Company: SUN PHARM

Medication Guide

Summary Review

Products on NDA 205583

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205583

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/28/2014	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205583s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205583Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205583Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205583Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/18/2023	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205583s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205583Orig1s014ltr.pdf
12/10/2019	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205583s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205583Orig1s010ltr.pdf
12/19/2017	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205583s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205583Orig1s006ltr.pdf
01/04/2017	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205583s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205583Orig1s005ltr.pdf
02/03/2015	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
07/18/2014	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205583s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205583Orig1s001,s003ltr.pdf
07/18/2014	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205583s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205583Orig1s001,s003ltr.pdf

Labels for NDA 205583

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/18/2023	SUPPL-14	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205583s014lbl.pdf
08/18/2023	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205583s014lbl.pdf
12/10/2019	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205583s010lbl.pdf
12/19/2017	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205583s006lbl.pdf
01/04/2017	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205583s005lbl.pdf
07/18/2014	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205583s001s003lbl.pdf
07/18/2014	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205583s001s003lbl.pdf
01/28/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205583s000lbl.pdf

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