FDA.reportPublic FDA data

Application 021936

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SPIRIVA RESPIMATTIOTROPIUM BROMIDESPRAY, METERED;INHALATIONEQ 0.0025MG BASE/INHYesYes
002SPIRIVA RESPIMATTIOTROPIUM BROMIDESPRAY, METERED;INHALATIONEQ 0.00125MG BASE/INHYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0597-0100Spiriva Respimattiotropium bromide inhalation sprayBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0100Spiriva Respimattiotropium bromide inhalation sprayBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0100Spiriva Respimattiotropium bromide inhalation sprayBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0100Spiriva Respimattiotropium bromide inhalation sprayBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80798SUPPL 2025-01-02
80786SUPPL 2024-12-30
57726SUPPL2019-02-21
57701SUPPL2019-02-19
47252SUPPL2017-02-16
16602SUPPL2016-06-13
6490SUPPL2016-06-10
37907SUPPL2016-02-17
28878SUPPL2016-01-20
44659ORIG2015-07-02
42354ORIG2015-07-02
37906ORIG2014-09-26
6489ORIG2014-09-26
52375ORIG1900-01-01
51572ORIG1900-01-01
51571ORIG1900-01-01
51570ORIG1900-01-01