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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206769
Company: TEVA PHARMS USA

Summary Review

Products on NDA 206769

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ARGATROBAN IN 0.9% SODIUM CHLORIDE	ARGATROBAN	250MG/250ML (1MG/ML)	INJECTABLE;INTRAVENOUS	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206769

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/15/2014	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/2014/206769s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206769Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206769Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206769Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/29/2019	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206769s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206769Orig1s004ltr.pdf
08/25/2017	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206769s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206769Orig1s003ltr.pdf
05/25/2016	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206769s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206769Orig1s002ltr.pdf

Labels for NDA 206769

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/29/2019	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206769s004lbl.pdf
08/25/2017	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206769s003lbl.pdf
05/25/2016	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206769s002lbl.pdf
12/15/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206769s000lbl.pdf

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