Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020883
Company: NOVARTIS PHARMS CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARGATROBAN ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE;INJECTION 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
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.

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

ARGATROBAN

INJECTABLE;INJECTION; 250MG/2.5ML (100MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ARGATROBAN ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE;INJECTION Prescription No AP 201811 FRESENIUS KABI USA
ARGATROBAN ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE;INJECTION Prescription No AP 203049 HIKMA PHARM CO LTD
ARGATROBAN ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE;INJECTION Prescription No AP 204120 HOSPIRA INC
ARGATROBAN ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE;INJECTION Prescription No AP 202626 MYLAN INSTITUTIONAL
ARGATROBAN ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE;INJECTION Prescription Yes AP 020883 NOVARTIS PHARMS CORP
ARGATROBAN ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE;INJECTION Prescription No AP 091665 PAR STERILE PRODUCTS

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