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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204683
Company: OSMOTICA PHARM CORP

Medication Guide

Summary Review

Products on NDA 204683

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204683

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/10/2013	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/2013/204683s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204683Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204683Orig1s000TOC.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204683Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/20/2021	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204683s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204683Orig1s007; 022104Orig1s021ltr.pdf
01/29/2019	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204683s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204683Orig1s006ltr.pdf
12/19/2017	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204683s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204683Orig1s005,022104Orig1s016ltr.pdf
01/04/2017	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204683s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204683Orig1s004ltr.pdf
09/06/2016	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204683s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204683Orig1s003ltr.pdf
07/16/2014	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204683s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204683Orig1s002ltr.pdf
10/01/2013	SUPPL-1	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204683s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204683Orig1s001ltr.pdf

Labels for NDA 204683

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/20/2021	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204683s007lbl.pdf
01/29/2019	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204683s006lbl.pdf
12/19/2017	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204683s005lbl.pdf
01/04/2017	SUPPL-4	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204683s004lbl.pdf
01/04/2017	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204683s004lbl.pdf
09/06/2016	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204683s003lbl.pdf
07/16/2014	SUPPL-2	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204683s002lbl.pdf
07/16/2014	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204683s002lbl.pdf
10/01/2013	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204683s001lbl.pdf
10/01/2013	SUPPL-1	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204683s001lbl.pdf
07/10/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204683s000lbl.pdf

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