Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 201743
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARGATROBAN IN DEXTROSE ARGATROBAN 125MG/125ML (1MG/ML) SOLUTION;IV (INFUSION) Discontinued None No No
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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