FDA.reportPublic FDA data

Application 206756

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001STIOLTO RESPIMATOLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDESPRAY, METERED;INHALATIONEQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INHYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0597-0155Stiolto Respimattiotropium bromide and olodaterolBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0155Stiolto Respimattiotropium bromide and olodaterolBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0155Stiolto Respimattiotropium bromide and olodaterolBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0155Stiolto Respimattiotropium bromide and olodaterolBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0155Stiolto Respimattiotropium bromide and olodaterolBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80795SUPPL 2025-01-02
80794SUPPL 2025-01-02
58943SUPPL2019-06-04
58898SUPPL2019-05-31
55934SUPPL2018-10-15
55848SUPPL2018-10-05
47262SUPPL2017-02-17
43527ORIG2016-06-27
19734SUPPL2016-06-13
10593SUPPL2016-06-10
32824SUPPL2016-03-22
19733SUPPL2016-03-22
19732SUPPL2015-06-19
10592SUPPL2015-06-18
32823ORIG2015-05-21
19731ORIG2015-05-21