NDA 020685

MERCK SHARP DOHME

FDA Drug Application

Application #020685

Documents

• Letter: 2004-05-07
• Letter: 2002-01-25
• Letter: 2002-09-19
• Letter: 2003-06-22
• Letter: 2004-12-29
• Letter: 2006-08-11
• Letter: 2006-12-28
• Letter: 2007-07-24
• Letter: 2008-12-18
• Letter: 2009-11-19
• Letter: 2010-04-28
• Letter: 2011-06-17
• Letter: 2014-07-28
• Letter: 2015-04-03
• Label: 2004-05-07
• Label: 2004-05-07
• Label: 2002-09-19
• Label: 2004-12-29
• Label: 2006-01-13
• Label: 2006-08-09
• Label: 2006-12-14
• Label: 2007-07-24
• Label: 2008-06-05
• Label: 2009-10-21
• Label: 2010-05-03
• Label: 2010-11-19
• Label: 2012-02-22
• Label: 2015-04-07
• Review: 2003-04-25
• Review: 2007-09-26
• Letter: 2001-03-21
• Letter: 2004-05-07
• Letter: 2002-06-20
• Letter: 2002-06-20
• Letter: 2004-01-14
• Letter: 2006-01-20
• Letter: 2008-04-18
• Letter: 2008-04-22
• Letter: 2012-02-27
• Label: 2002-06-20
• Label: 2002-06-20
• Label: 2002-06-20
• Label: 2003-06-22
• Label: 2004-01-15
• Label: 2008-04-23
• Label: 2009-01-02
• Label: 2014-07-28
• Review: 1997-02-19
• Review: 1998-12-17
• Review: 2004-05-06
• Review: 2007-09-26
• Review: 2007-09-26
• Review: 2007-09-26
• Review: 2007-09-26
• Review: 2007-09-26
• Letter: 2016-09-20
• Label: 2016-09-20
• Review: 2019-02-15

Application Sponsors

NDA 020685

MERCK SHARP DOHME

Marketing Status

• Prescription: 001
• Discontinued: 003
• Discontinued: 005
• Discontinued: 006

Application Products

001	CAPSULE;ORAL	EQ 400MG BASE	1	CRIXIVAN	INDINAVIR SULFATE
003	CAPSULE;ORAL	EQ 200MG BASE	1	CRIXIVAN	INDINAVIR SULFATE
005	CAPSULE;ORAL	EQ 333MG BASE	0	CRIXIVAN	INDINAVIR SULFATE
006	CAPSULE;ORAL	EQ 100MG BASE	0	CRIXIVAN	INDINAVIR SULFATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1996-03-13	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1997-01-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1996-12-05	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1997-04-03	PRIORITY
LABELING; Labeling	SUPPL	5	AP	1997-02-19	STANDARD
LABELING; Labeling	SUPPL	6	AP	1997-03-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1997-04-16	PRIORITY
LABELING; Labeling	SUPPL	8	AP	1997-09-26	STANDARD
LABELING; Labeling	SUPPL	9	AP	1997-09-26	STANDARD
LABELING; Labeling	SUPPL	10	AP	1997-11-21	STANDARD
LABELING; Labeling	SUPPL	11	AP	1997-09-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1997-08-12	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1997-09-26	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1998-01-15	PRIORITY
LABELING; Labeling	SUPPL	15	AP	1997-10-01	STANDARD
EFFICACY; Efficacy	SUPPL	16	AP	1998-02-06	UNKNOWN
LABELING; Labeling	SUPPL	17	AP	1998-02-06	STANDARD
LABELING; Labeling	SUPPL	18	AP	1998-02-06	STANDARD
LABELING; Labeling	SUPPL	19	AP	1997-11-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1998-01-15	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1998-06-12	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1998-12-17	PRIORITY
LABELING; Labeling	SUPPL	23	AP	1999-06-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1998-12-02	PRIORITY
LABELING; Labeling	SUPPL	25	AP	1999-06-04	STANDARD
LABELING; Labeling	SUPPL	26	AP	1999-06-04	STANDARD
LABELING; Labeling	SUPPL	27	AP	1999-06-04	STANDARD
LABELING; Labeling	SUPPL	28	AP	1999-06-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1999-02-23	PRIORITY
LABELING; Labeling	SUPPL	30	AP	2000-10-23	STANDARD
LABELING; Labeling	SUPPL	31	AP	1999-06-04	STANDARD
LABELING; Labeling	SUPPL	32	AP	1999-06-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1999-03-12	PRIORITY
LABELING; Labeling	SUPPL	34	AP	1999-06-04	STANDARD
LABELING; Labeling	SUPPL	35	AP	2000-04-11	STANDARD
LABELING; Labeling	SUPPL	36	AP	1999-06-04	STANDARD
LABELING; Labeling	SUPPL	38	AP	2000-04-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1999-10-25	PRIORITY
LABELING; Labeling	SUPPL	40	AP	2000-10-23	STANDARD
LABELING; Labeling	SUPPL	41	AP	2001-03-21	STANDARD
LABELING; Labeling	SUPPL	42	AP	2000-04-11	STANDARD
EFFICACY; Efficacy	SUPPL	43	AP	2000-10-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	2000-04-19	PRIORITY
LABELING; Labeling	SUPPL	45	AP	2000-10-23	STANDARD
LABELING; Labeling	SUPPL	46	AP	2004-05-07	STANDARD
LABELING; Labeling	SUPPL	47	AP	2004-05-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	2001-07-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	2001-06-01	PRIORITY
LABELING; Labeling	SUPPL	50	AP	2002-01-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	51	AP	2001-07-13	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	2001-09-24	PRIORITY
LABELING; Labeling	SUPPL	53	AP	2002-01-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	54	AP	2001-10-26	PRIORITY
LABELING; Labeling	SUPPL	55	AP	2002-09-19	STANDARD
LABELING; Labeling	SUPPL	56	AP	2002-06-20	STANDARD
LABELING; Labeling	SUPPL	57	AP	2003-06-09	STANDARD
LABELING; Labeling	SUPPL	58	AP	2004-01-12	STANDARD
LABELING; Labeling	SUPPL	60	AP	2004-12-23	STANDARD
LABELING; Labeling	SUPPL	61	AP	2006-01-12	STANDARD
LABELING; Labeling	SUPPL	62	AP	2006-08-07	STANDARD
LABELING; Labeling	SUPPL	63	AP	2006-12-08	STANDARD
LABELING; Labeling	SUPPL	64	AP	2007-07-18	STANDARD
LABELING; Labeling	SUPPL	65	AP	2008-04-16	STANDARD
LABELING; Labeling	SUPPL	66	AP	2008-04-17	STANDARD
LABELING; Labeling	SUPPL	68	AP	2008-12-10	STANDARD
LABELING; Labeling	SUPPL	69	AP	2009-10-15	STANDARD
LABELING; Labeling	SUPPL	71	AP	2010-04-26	901 REQUIRED
LABELING; Labeling	SUPPL	72	AP	2011-06-10	UNKNOWN
LABELING; Labeling	SUPPL	73	AP	2010-11-19	UNKNOWN
LABELING; Labeling	SUPPL	75	AP	2012-02-17	901 REQUIRED
LABELING; Labeling	SUPPL	76	AP	2014-07-24	STANDARD
LABELING; Labeling	SUPPL	77	AP	2015-03-27	901 REQUIRED
LABELING; Labeling	SUPPL	78	AP	2016-09-15	901 REQUIRED

Submissions Property Types

ORIG	1	Null	41
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	7	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	24	Null	0
SUPPL	29	Null	0
SUPPL	33	Null	0
SUPPL	39	Null	0
SUPPL	44	Null	0
SUPPL	48	Null	0
SUPPL	49	Null	0
SUPPL	51	Null	0
SUPPL	52	Null	0
SUPPL	54	Null	0
SUPPL	57	Null	9
SUPPL	58	Null	9
SUPPL	69	Null	7
SUPPL	71	Null	7
SUPPL	72	Null	6
SUPPL	75	Null	7
SUPPL	76	Null	15
SUPPL	77	Null	6
SUPPL	78	Null	6

CDER Filings

MERCK SHARP DOHME

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20685
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["",""]
            [products] => [{"drugName":"CRIXIVAN","activeIngredients":"INDINAVIR SULFATE","strength":"EQ 400MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"CRIXIVAN","activeIngredients":"INDINAVIR SULFATE","strength":"EQ 200MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"CRIXIVAN","activeIngredients":"INDINAVIR SULFATE","strength":"EQ 333MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CRIXIVAN","activeIngredients":"INDINAVIR SULFATE","strength":"EQ 100MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/15\/2016","submission":"SUPPL-78","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020685s078lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2015","submission":"SUPPL-77","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020685s077lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2015","submission":"SUPPL-77","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020685s077lbl.pdf\"}]","notes":""},{"actionDate":"07\/24\/2014","submission":"SUPPL-76","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020685s076lbl.pdf\"}]","notes":""},{"actionDate":"07\/24\/2014","submission":"SUPPL-76","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020685s076lbl.pdf\"}]","notes":""},{"actionDate":"02\/17\/2012","submission":"SUPPL-75","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020685s075lbl.pdf\"}]","notes":""},{"actionDate":"02\/17\/2012","submission":"SUPPL-75","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020685s075lbl.pdf\"}]","notes":""},{"actionDate":"11\/19\/2010","submission":"SUPPL-73","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020685s073lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2010","submission":"SUPPL-71","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020685s071lbl.pdf\"}]","notes":""},{"actionDate":"10\/15\/2009","submission":"SUPPL-69","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020685s069lbl.pdf\"}]","notes":""},{"actionDate":"12\/10\/2008","submission":"SUPPL-68","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020685s068lbl.pdf\"}]","notes":""},{"actionDate":"04\/17\/2008","submission":"SUPPL-66","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020685s066lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2008","submission":"SUPPL-65","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020685s065lbl.pdf\"}]","notes":""},{"actionDate":"07\/18\/2007","submission":"SUPPL-64","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020685s064lbl.pdf\"}]","notes":""},{"actionDate":"12\/08\/2006","submission":"SUPPL-63","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020685s063lbl.pdf\"}]","notes":""},{"actionDate":"08\/07\/2006","submission":"SUPPL-62","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020685s062lbl.pdf\"}]","notes":""},{"actionDate":"01\/12\/2006","submission":"SUPPL-61","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020685s061lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2004","submission":"SUPPL-60","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20685s060lbl.pdf\"}]","notes":""},{"actionDate":"05\/07\/2004","submission":"SUPPL-47","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20685slr046,047_crixivan_lbl.pdf\"}]","notes":""},{"actionDate":"05\/07\/2004","submission":"SUPPL-46","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20685slr046,047_crixivan_lbl.pdf\"}]","notes":""},{"actionDate":"01\/12\/2004","submission":"SUPPL-58","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20685slr058_crixivan_lbl.pdf\"}]","notes":""},{"actionDate":"06\/09\/2003","submission":"SUPPL-57","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20685slr057_crixivan_lbl.pdf\"}]","notes":""},{"actionDate":"09\/19\/2002","submission":"SUPPL-55","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20685s55lbl.pdf\"}]","notes":""},{"actionDate":"06\/20\/2002","submission":"SUPPL-56","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20685s050s053s056lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2002","submission":"SUPPL-53","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20685s050s053s056lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2002","submission":"SUPPL-50","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20685s050s053s056lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CRIXIVAN","submission":"INDINAVIR SULFATE","actionType":"EQ 400MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CRIXIVAN","submission":"INDINAVIR SULFATE","actionType":"EQ 200MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"CRIXIVAN","submission":"INDINAVIR SULFATE","actionType":"EQ 333MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CRIXIVAN","submission":"INDINAVIR SULFATE","actionType":"EQ 100MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2016-09-15
        )

)