FDA.reportPublic FDA data

Application 021785

Type
NDA
Sponsor
HOFFMANN-LA ROCHE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INVIRASESAQUINAVIR MESYLATETABLET;ORALEQ 500MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0004-0244Invirasesaquinavir mesylateGenentech, Inc.NDACurrent
0004-0244Invirasesaquinavir mesylateGenentech, Inc.NDACurrent
0004-0244Invirasesaquinavir mesylateGenentech, Inc.NDACurrent
0004-0244Invirasesaquinavir mesylateGenentech, Inc.NDACurrent
0004-0244Invirasesaquinavir mesylateGenentech, Inc.NDACurrent
0004-0244Invirasesaquinavir mesylateGenentech, Inc.NDACurrent
0004-0244Invirasesaquinavir mesylateGenentech, Inc.NDACurrent
0004-0244Invirasesaquinavir mesylateGenentech, Inc.NDACurrent
0004-0244Invirasesaquinavir mesylateGenentech, Inc.NDACurrent
53808-0674Invirasesaquinavir mesylateState of Florida DOH Central PharmacyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64652SUPPL2020-09-22
64651SUPPL2020-09-22
64631SUPPL2020-09-21
61428SUPPL2019-12-23
61427SUPPL2019-12-23
61385SUPPL2019-12-23
58184SUPPL2019-04-02
58183SUPPL2019-04-02
58146SUPPL2019-03-29
56367SUPPL2018-11-08
53067SUPPL2018-03-20
53055SUPPL2018-03-19
45382SUPPL2016-09-23
45342SUPPL2016-09-20
37650SUPPL2016-03-03
28602SUPPL2016-03-02
28604SUPPL2015-12-17
16371SUPPL2015-12-17
37649SUPPL2015-04-28
28601SUPPL2015-04-22
16370SUPPL2015-04-02
28603SUPPL2015-03-31
16368SUPPL2012-12-04
6185SUPPL2012-12-04
6187SUPPL2012-02-27
16369SUPPL2012-02-22
6186SUPPL2011-05-31
23299ORIG2010-10-13
37648SUPPL2010-10-12
28600SUPPL2010-10-12
16367SUPPL2010-05-07
6184SUPPL2010-04-29
28599SUPPL2010-01-26
16366SUPPL2010-01-24
42309SUPPL2007-07-27
16365SUPPL2007-07-16
6183SUPPL2007-07-16
28598SUPPL2007-04-09
37647SUPPL2007-04-06
21818ORIG2006-09-27
43571SUPPL2005-11-04
23075SUPPL2005-11-04
37646SUPPL2005-09-14
28597SUPPL2005-09-14
16364SUPPL2005-09-14
6182SUPPL2005-09-14
28596ORIG2004-12-30
16363ORIG2004-12-30