Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020685
Company: MERCK SHARP DOHME
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 |