FDA.reportPublic FDA data

Application 207070

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SPIRIVA RESPIMATTIOTROPIUM BROMIDESPRAY;INHALATION2.5MCGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0597-0160Spiriva Respimattiotropium bromide inhalation sprayBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0160Spiriva Respimattiotropium bromide inhalation sprayBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0160Spiriva Respimattiotropium bromide inhalation sprayBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0160Spiriva Respimattiotropium bromide inhalation sprayBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23030ORIG2016-06-27
40581ORIG2015-09-23
32842ORIG2015-09-17
24524ORIG2015-09-17
51687ORIG1900-01-01
51686ORIG1900-01-01
51685ORIG1900-01-01
51684ORIG1900-01-01
51683ORIG1900-01-01