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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022239
Company: ENDO VENTURES LTD

Summary Review

Products on NDA 022239

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SUMAVEL DOSEPRO	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE;SUBCUTANEOUS	Discontinued	None	Yes	No
SUMAVEL DOSEPRO	SUMATRIPTAN SUCCINATE	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE;SUBCUTANEOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022239

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/15/2009	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022239lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022239s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022239_sumavel_dosepro_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022239s000Sumr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/02/2020	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022239s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022239Orig1s007ltr.pdf
12/26/2019	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022239s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022239Orig1s006ltr.pdf
11/26/2013	SUPPL-5	Efficacy-Manufacturing Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022239s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022239Orig1s005ltr.pdf
06/02/2016	SUPPL-4	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022239s004lbl.pdf
06/27/2011	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022239s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022239s002ltr.pdf

Labels for NDA 022239

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/02/2020	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022239s007lbl.pdf
12/26/2019	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022239s006lbl.pdf
06/02/2016	SUPPL-4	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022239s004lbl.pdf
11/26/2013	SUPPL-5	Efficacy-Manufacturing Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022239s005lbl.pdf
06/27/2011	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022239s002lbl.pdf
07/15/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022239lbl.pdf

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