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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020685
Company: MERCK SHARP DOHME

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CRIXIVAN INDINAVIR SULFATE EQ 400MG BASE CAPSULE;ORAL Discontinued None Yes No
CRIXIVAN INDINAVIR SULFATE EQ 200MG BASE CAPSULE;ORAL Discontinued None Yes No
CRIXIVAN INDINAVIR SULFATE EQ 333MG BASE CAPSULE;ORAL Discontinued None No No
CRIXIVAN INDINAVIR SULFATE EQ 100MG BASE CAPSULE;ORAL Discontinued None No No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
09/15/2016 SUPPL-78 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020685s078lbl.pdf
03/27/2015 SUPPL-77 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020685s077lbl.pdf
03/27/2015 SUPPL-77 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020685s077lbl.pdf
07/24/2014 SUPPL-76 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020685s076lbl.pdf
07/24/2014 SUPPL-76 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020685s076lbl.pdf
02/17/2012 SUPPL-75 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020685s075lbl.pdf
02/17/2012 SUPPL-75 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020685s075lbl.pdf
11/19/2010 SUPPL-73 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020685s073lbl.pdf
04/26/2010 SUPPL-71 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020685s071lbl.pdf
10/15/2009 SUPPL-69 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020685s069lbl.pdf
12/10/2008 SUPPL-68 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020685s068lbl.pdf
04/17/2008 SUPPL-66 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020685s066lbl.pdf
04/16/2008 SUPPL-65 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020685s065lbl.pdf
07/18/2007 SUPPL-64 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020685s064lbl.pdf
12/08/2006 SUPPL-63 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020685s063lbl.pdf
08/07/2006 SUPPL-62 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020685s062lbl.pdf
01/12/2006 SUPPL-61 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020685s061lbl.pdf
12/23/2004 SUPPL-60 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20685s060lbl.pdf
05/07/2004 SUPPL-47 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20685slr046,047_crixivan_lbl.pdf
05/07/2004 SUPPL-46 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20685slr046,047_crixivan_lbl.pdf
01/12/2004 SUPPL-58 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20685slr058_crixivan_lbl.pdf
06/09/2003 SUPPL-57 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20685slr057_crixivan_lbl.pdf
09/19/2002 SUPPL-55 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20685s55lbl.pdf
06/20/2002 SUPPL-56 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20685s050s053s056lbl.pdf
01/25/2002 SUPPL-53 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20685s050s053s056lbl.pdf
01/25/2002 SUPPL-50 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20685s050s053s056lbl.pdf
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