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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020718
Company: MSD SUB MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INTEGRILIN EPTIFIBATIDE 2MG/ML INJECTABLE;INJECTION Discontinued None Yes No
INTEGRILIN EPTIFIBATIDE 75MG/100ML INJECTABLE;INJECTION Discontinued None Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/28/2021 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020718s039lbl.pdf
03/25/2013 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020718s037lbl.pdf
03/30/2011 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020718s034lbl.pdf
12/15/2008 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020718s028lbl.pdf
10/12/2005 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020718s025lbl.pdf
06/16/2003 SUPPL-17 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20718se8-017_integrilin_lbl.pdf
06/08/2001 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20718s010s013lbl.pdf
06/08/2001 SUPPL-10 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20718s010s013lbl.pdf
09/20/1999 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20718s02lbl.pdf
05/18/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20718lbl.pdf
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