FDA.reportPublic FDA data

Application 020628

Type
NDA
Sponsor
HOFFMANN LA ROCHE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INVIRASESAQUINAVIR MESYLATECAPSULE;ORALEQ 200MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0004-0245Invirasesaquinavir mesylateGenentech, Inc.NDACurrent
0004-0245Invirasesaquinavir mesylateGenentech, Inc.NDACurrent
0004-0245Invirasesaquinavir mesylateGenentech, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58182SUPPL2019-04-02
58181SUPPL2019-04-02
58144SUPPL2019-03-29
57679ORIG2019-02-15
56363SUPPL2018-11-08
53066SUPPL2018-03-20
53054SUPPL2018-03-19
45377SUPPL2016-09-23
45341SUPPL2016-09-20
12870SUPPL2016-03-03
25356SUPPL2016-03-02
12871SUPPL2015-12-17
2911SUPPL2015-12-17
34986SUPPL2015-04-28
25355SUPPL2015-04-22
34987SUPPL2015-04-02
2910SUPPL2015-03-31
12869SUPPL2012-12-04
2909SUPPL2012-12-04
25354SUPPL2012-02-27
34985SUPPL2012-02-22
25353SUPPL2011-05-31
52336SUPPL2010-10-26
52335SUPPL2010-10-26
52334SUPPL2010-10-26
52333SUPPL2010-10-26
52332SUPPL2010-10-26
52331SUPPL2010-10-26
23169ORIG2010-10-13
34984SUPPL2010-10-12
25352SUPPL2010-10-12
34983SUPPL2010-05-07
2908SUPPL2010-04-29
25351SUPPL2010-01-26
34982SUPPL2010-01-24
41494SUPPL2007-11-19
20774SUPPL2007-09-26
20776SUPPL2007-08-06
34981SUPPL2007-07-16
25350SUPPL2007-07-16
2907SUPPL2007-04-09
34980SUPPL2007-04-06
43562SUPPL2005-11-04
23059SUPPL2005-11-04
34979SUPPL2005-09-14
12868SUPPL2005-09-14
2906SUPPL2005-09-14
2905SUPPL2005-09-14
20775SUPPL2005-04-27
23058SUPPL2004-02-03
34978SUPPL2004-01-15
25349SUPPL2004-01-14
25348SUPPL2002-06-24
12867SUPPL2002-06-24
41493SUPPL1997-02-27
51651SUPPL1900-01-01
51650SUPPL1900-01-01
51649SUPPL1900-01-01