FDA.reportPublic FDA data

Application 203108

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001STRIVERDI RESPIMATOLODATEROL HYDROCHLORIDESPRAY, METERED;INHALATIONEQ 0.0025MG BASE/INHYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0597-0192Striverdi Respimatolodaterol respimat inhalation sprayBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0192Striverdi Respimatolodaterol respimat inhalation sprayBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0192Striverdi Respimatolodaterol respimat inhalation sprayBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0192Striverdi Respimatolodaterol respimat inhalation sprayBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80796SUPPL 2025-01-02
80783SUPPL 2024-12-30
58949SUPPL2019-06-04
58899SUPPL2019-05-31
53621SUPPL2018-04-05
53597SUPPL2018-04-03
52754ORIG2018-02-28
19426SUPPL2016-06-13
10162SUPPL2016-06-10
24428ORIG2014-09-08
22911ORIG2014-09-08
40264ORIG2014-08-01
32377ORIG2014-08-01