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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020873
Company: SANDOZ

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANGIOMAX BIVALIRUDIN 250MG/VIAL INJECTABLE;INTRAVENOUS 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
12/15/2000 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20873lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20873ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20873_Angiomax.html
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/02/2019 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020873s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020873Orig1s039ltr.pdf
12/21/2018 SUPPL-37 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020873s037lbl.pdf
03/21/2016 SUPPL-36 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020873s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020873Orig1s036ltr.pdf
09/03/2015 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.
03/08/2016 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.
05/10/2016 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.
05/29/2015 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.
08/07/2014 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.
07/30/2013 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.
05/17/2013 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020873s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020873Orig1s029ltr.pdf
02/15/2013 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.
11/09/2012 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.
05/30/2012 SUPPL-25 Labeling-Package Insert

Label is not available on this site.
06/23/2010 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020873s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020873s023ltr.pdf
09/02/2005 SUPPL-14 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020873s014ltr.pdf
11/30/2005 SUPPL-11 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020873s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020873s011ltr.pdf
05/07/2004 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20873slr009ltr.pdf
06/13/2005 SUPPL-6 Efficacy-New Indication Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020873s006ltr.pdf
06/20/2002 SUPPL-4 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20873s004LTR.pdf
06/22/2001 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.
05/14/2001 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.
04/02/2001 SUPPL-1 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
07/02/2019 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020873s039lbl.pdf
12/21/2018 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020873s037lbl.pdf
03/21/2016 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020873s036lbl.pdf
03/21/2016 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020873s036lbl.pdf
05/17/2013 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020873s029lbl.pdf
06/23/2010 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020873s023lbl.pdf
11/30/2005 SUPPL-11 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020873s011lbl.pdf
12/15/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20873lbl.pdf

ANGIOMAX

INJECTABLE;INTRAVENOUS; 250MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANGIOMAX BIVALIRUDIN 250MG/VIAL INJECTABLE;INTRAVENOUS Prescription Yes AP 020873 SANDOZ
BIVALIRUDIN BIVALIRUDIN 250MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 206551 ACCORD HLTHCARE
BIVALIRUDIN BIVALIRUDIN 250MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 201577 DR REDDYS
BIVALIRUDIN BIVALIRUDIN 250MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 090189 FRESENIUS KABI USA
BIVALIRUDIN BIVALIRUDIN 250MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 091602 MEITHEAL
BIVALIRUDIN BIVALIRUDIN 250MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 202471 MYLAN INSTITUTIONAL
BIVALIRUDIN BIVALIRUDIN 250MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 210031 SHUANGCHENG
BIVALIRUDIN BIVALIRUDIN 250MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 213078 SLATE RUN PHARMA
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