FDA.reportPublic FDA data

Application 022292

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001APTIVUSTIPRANAVIRSOLUTION;ORAL100MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0597-0002AptivustipranavirBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0002AptivustipranavirBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0002AptivustipranavirBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0002AptivustipranavirBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63655SUPPL2020-06-22
63654SUPPL2020-06-22
63653SUPPL2020-06-22
63632SUPPL2020-06-19
54856SUPPL2018-07-06
54717SUPPL2018-06-28
45376SUPPL2016-09-23
45344SUPPL2016-09-20
38528SUPPL2015-04-07
29547SUPPL2015-04-01
38527SUPPL2014-04-08
29546SUPPL2014-04-08
29545SUPPL2012-02-27
17212SUPPL2012-02-22
29544SUPPL2011-04-07
38526SUPPL2011-04-06
7197SUPPL2010-09-07
38525SUPPL2010-08-16
44728ORIG2010-05-12
42481ORIG2010-05-12
17211SUPPL2010-05-07
7196SUPPL2010-05-03
38524SUPPL2009-06-24
7195SUPPL2009-06-24
17210ORIG2008-06-26
7194ORIG2008-06-26