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 |
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-Patient Package Insert, Labeling-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-Patient Package Insert, Labeling-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-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 |