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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020883
Company: SANDOZ

Summary Review

Products on NDA 020883

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ARGATROBAN	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020883

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/2000	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20883lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20883ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-883_Acova.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/08/2017	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020883s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020883Orig1s019ltr.pdf
05/25/2016	SUPPL-18	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020883s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020883Orig1s018ltr.pdf
03/10/2014	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020883s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020883Orig1s016ltr.pdf
01/26/2016	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
05/05/2008	SUPPL-14	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF) Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020883s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020883se8-014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020883se8-014_sumr.pdf
04/11/2005	SUPPL-10	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020883s010ltr.pdf
09/01/2005	SUPPL-9	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020883s009ltr.pdf
10/29/2003	SUPPL-7	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20883slr007ltr.pdf
07/01/2002	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
04/03/2002	SUPPL-4	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20883s4lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20883s4ltr.pdf
08/22/2000	SUPPL-3	Labeling		Label is not available on this site.

Labels for NDA 020883

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/08/2017	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020883s019lbl.pdf
05/25/2016	SUPPL-18	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020883s018lbl.pdf
03/10/2014	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020883s016lbl.pdf
05/05/2008	SUPPL-14	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020883s014lbl.pdf
04/03/2002	SUPPL-4	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20883s4lbl.pdf
06/30/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20883lbl.pdf

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