Drugs@FDA: FDA Approved Drug Products

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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 Prescription None Yes Yes
CRIXIVAN INDINAVIR SULFATE EQ 200MG BASE CAPSULE;ORAL Prescription 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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/13/1996 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020685Orig1s000rev.pdf
Supplements
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)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020685s078lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020685Orig1s078ltr.pdf
03/27/2015 SUPPL-77 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020685s077lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020685Orig1s077ltr.pdf
07/24/2014 SUPPL-76 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020685s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020685Orig1s076ltr.pdf
02/17/2012 SUPPL-75 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020685s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020685s075ltr.pdf
11/19/2010 SUPPL-73 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020685s073lbl.pdf
06/10/2011 SUPPL-72 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf
04/26/2010 SUPPL-71 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020685s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020685s071ltr.pdf
10/15/2009 SUPPL-69 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020685s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020685s069ltr.pdf
12/10/2008 SUPPL-68 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020685s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020685s068ltr.pdf
04/17/2008 SUPPL-66 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020685s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020685s066ltr.pdf
04/16/2008 SUPPL-65 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020685s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020685s065ltr.pdf
07/18/2007 SUPPL-64 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020685s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020685s064ltr.pdf
12/08/2006 SUPPL-63 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020685s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020685s063ltr.pdf
08/07/2006 SUPPL-62 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020685s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020685s062LTR.pdf
01/12/2006 SUPPL-61 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020685s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020685s061ltr.pdf
12/23/2004 SUPPL-60 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20685s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20685s060ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020685_S060_Crixivan.pdf
01/12/2004 SUPPL-58 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20685slr058_crixivan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20685slr058ltr.pdf
06/09/2003 SUPPL-57 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20685slr057_crixivan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20685slr057ltr.pdf
06/20/2002 SUPPL-56 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20685s050s053s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20685s050,053,056LTR.pdf
09/19/2002 SUPPL-55 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20685s55lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20685slr055ltr.pdf
10/26/2001 SUPPL-54 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020685_S054_Crixivan.pdf
01/25/2002 SUPPL-53 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20685s050s053s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20685s050,053,056LTR.pdf
09/24/2001 SUPPL-52 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020685_S052_Crixivan.pdf
07/13/2001 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

01/25/2002 SUPPL-50 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20685s050s053s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20685s50s53ltr.pdf
06/01/2001 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

07/10/2001 SUPPL-48 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/07/2004 SUPPL-47 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20685slr046,047_crixivan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20685slr046,047ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020685_S047_Crixivan.pdf
05/07/2004 SUPPL-46 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20685slr046,047_crixivan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20685slr046,047ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020685_S046_Crixivan.pdf
10/23/2000 SUPPL-45 Labeling

Label is not available on this site.

04/19/2000 SUPPL-44 Manufacturing (CMC)-Formulation Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020685_S044_Crixivan.pdf
10/23/2000 SUPPL-43 Efficacy-Labeling Change With Clinical Data Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-685-S043.pdf
04/11/2000 SUPPL-42 Labeling

Label is not available on this site.

03/21/2001 SUPPL-41 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20685s41ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20685s041.pdf
10/23/2000 SUPPL-40 Labeling

Label is not available on this site.

10/25/1999 SUPPL-39 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/11/2000 SUPPL-38 Labeling

Label is not available on this site.

06/04/1999 SUPPL-36 Labeling

Label is not available on this site.

04/11/2000 SUPPL-35 Labeling

Label is not available on this site.

06/04/1999 SUPPL-34 Labeling

Label is not available on this site.

03/12/1999 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/04/1999 SUPPL-32 Labeling

Label is not available on this site.

06/04/1999 SUPPL-31 Labeling

Label is not available on this site.

10/23/2000 SUPPL-30 Labeling

Label is not available on this site.

02/23/1999 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

06/04/1999 SUPPL-28 Labeling

Label is not available on this site.

06/04/1999 SUPPL-27 Labeling

Label is not available on this site.

06/04/1999 SUPPL-26 Labeling

Label is not available on this site.

06/04/1999 SUPPL-25 Labeling

Label is not available on this site.

12/02/1998 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/04/1999 SUPPL-23 Labeling

Label is not available on this site.

12/17/1998 SUPPL-22 Manufacturing (CMC)-Formulation Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020685s022.pdf
06/12/1998 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

01/15/1998 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

11/18/1997 SUPPL-19 Labeling

Label is not available on this site.

02/06/1998 SUPPL-18 Labeling

Label is not available on this site.

02/06/1998 SUPPL-17 Labeling

Label is not available on this site.

02/06/1998 SUPPL-16 Efficacy-Accelerated Approval

Label is not available on this site.

10/01/1997 SUPPL-15 Labeling

Label is not available on this site.

01/15/1998 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

09/26/1997 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

08/12/1997 SUPPL-12 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/26/1997 SUPPL-11 Labeling

Label is not available on this site.

11/21/1997 SUPPL-10 Labeling

Label is not available on this site.

09/26/1997 SUPPL-9 Labeling

Label is not available on this site.

09/26/1997 SUPPL-8 Labeling

Label is not available on this site.

04/16/1997 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

03/24/1997 SUPPL-6 Labeling

Label is not available on this site.

02/19/1997 SUPPL-5 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020685_s005ap.pdf
04/03/1997 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

12/05/1996 SUPPL-3 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/17/1997 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

08/22/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020685s076lbl.pdf
07/24/2014 SUPPL-76 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020685s076lbl.pdf
02/17/2012 SUPPL-75 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020685s075lbl.pdf
02/17/2012 SUPPL-75 Labeling-Patient 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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