Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022485
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARGATROBAN IN SODIUM CHLORIDE ARGATROBAN 125MG/125ML (1MG/ML) INJECTABLE;IV (INFUSION) Prescription AP Yes Yes
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/2011/022485lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022485s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022485s000(1)ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022485_argatroban_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022485Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/26/2016 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022485s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022485Orig1s009ltr.pdf
12/01/2015 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/11/2014 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/26/2016 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022485s009lbl.pdf
05/09/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022485lbl.pdf

ARGATROBAN IN SODIUM CHLORIDE

INJECTABLE;IV (INFUSION); 125MG/125ML (1MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ARGATROBAN IN SODIUM CHLORIDE ARGATROBAN 125MG/125ML (1MG/ML) INJECTABLE;IV (INFUSION) Prescription No AP 205570 GLAND PHARMA LTD
ARGATROBAN IN SODIUM CHLORIDE ARGATROBAN 125MG/125ML (1MG/ML) INJECTABLE;IV (INFUSION) Prescription Yes AP 022485 SANDOZ

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