Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022434
Company: EAGLE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARGATROBAN IN SODIUM CHLORIDE ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE;IV (INFUSION) Prescription None 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
06/29/2011 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/2011/022434s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022434s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022434_argatroban_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022434Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/26/2016 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022434s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022434Orig1s010ltr.pdf
08/18/2015 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/05/2015 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/09/2014 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022434s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022434Orig1s006ltr.pdf
01/16/2014 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/10/2013 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/20/2013 SUPPL-3 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-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022434s010lbl.pdf
09/09/2014 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022434s006lbl.pdf
06/29/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022434s000lbl.pdf

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