An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 201743
Company: SANDOZ

Summary Review

Products on NDA 201743

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ARGATROBAN IN DEXTROSE	ARGATROBAN	125MG/125ML (1MG/ML)	SOLUTION;INTRAVENOUS	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 201743

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/09/2011	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201743lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201743s000(1)ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201743s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201743_argatroban_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201743Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/22/2018	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201743s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201743Orig1s002ltr.pdf
05/26/2016	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201743s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201743Orig1s001ltr.pdf

Labels for NDA 201743

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/22/2018	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201743s002lbl.pdf
05/26/2016	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201743s001lbl.pdf
05/09/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201743lbl.pdf

Top