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

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Spiriva RespimatTIOTROPIUM BROMIDE INHALATION SPRAYBoehringer Ingelheim Pharmaceuticals, Inc.7b656b14-fcaa-2741-f6f0-e0be48971c022025-11-25Warnings, Adverse reactionsExact identifier
application applno (NDA): 207070
application number: NDA207070
ndc (product): 0597-0160

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

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