FDA.reportPublic FDA data

Application 020685

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CRIXIVANINDINAVIR SULFATECAPSULE;ORALEQ 400MG BASEYesYes
003CRIXIVANINDINAVIR SULFATECAPSULE;ORALEQ 200MG BASEYesNo
005CRIXIVANINDINAVIR SULFATECAPSULE;ORALEQ 333MG BASENoNo
006CRIXIVANINDINAVIR SULFATECAPSULE;ORALEQ 100MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-0571CRIXIVANindinavir sulfateMerck Sharp & Dohme Corp.NDACurrent
0006-0571CRIXIVANindinavir sulfateMerck Sharp & Dohme Corp.NDACurrent
0006-0571CRIXIVANindinavir sulfateMerck Sharp & Dohme Corp.NDACurrent
0006-0573CRIXIVANindinavir sulfateMerck Sharp & Dohme Corp.NDACurrent
0006-0573CRIXIVANindinavir sulfateMerck Sharp & Dohme Corp.NDACurrent
0006-0573CRIXIVANindinavir sulfateMerck Sharp & Dohme Corp.NDACurrent
21695-366CRIXIVANindinavir sulfateRebel Distributors CorpNDACurrent
53808-0661CRIXIVANindinavir sulfateState of Florida DOH Central PharmacyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57688ORIG2019-02-15
45379SUPPL2016-09-20
45339SUPPL2016-09-20
13204SUPPL2015-04-07
3081SUPPL2015-04-03
35136SUPPL2014-07-28
3080SUPPL2014-07-28
25508SUPPL2012-02-27
13203SUPPL2012-02-22
3079SUPPL2011-06-17
13202SUPPL2010-11-19
13201SUPPL2010-05-03
3078SUPPL2010-04-28
3077SUPPL2009-11-19
13200SUPPL2009-10-21
35135SUPPL2009-01-02
3076SUPPL2008-12-18
13199SUPPL2008-06-05
35134SUPPL2008-04-23
25507SUPPL2008-04-22
25506SUPPL2008-04-18
41552SUPPL2007-09-26
41551SUPPL2007-09-26
41550SUPPL2007-09-26
41549SUPPL2007-09-26
41548SUPPL2007-09-26
20819SUPPL2007-09-26
13198SUPPL2007-07-24
3075SUPPL2007-07-24
3074SUPPL2006-12-28
13197SUPPL2006-12-14
3073SUPPL2006-08-11
13196SUPPL2006-08-09
25505SUPPL2006-01-20
13195SUPPL2006-01-13
13194SUPPL2004-12-29
3072SUPPL2004-12-29
25501SUPPL2004-05-07
13192SUPPL2004-05-07
13191SUPPL2004-05-07
3068SUPPL2004-05-07
41547SUPPL2004-05-06
35133SUPPL2004-01-15
25504SUPPL2004-01-14
35132SUPPL2003-06-22
3071SUPPL2003-06-22
20818SUPPL2003-04-25
13193SUPPL2002-09-19
3070SUPPL2002-09-19
35131SUPPL2002-06-20
35130SUPPL2002-06-20
35129SUPPL2002-06-20
25503SUPPL2002-06-20
25502SUPPL2002-06-20
3069SUPPL2002-01-25
25500SUPPL2001-03-21
41546SUPPL1998-12-17
41545SUPPL1997-02-19