FDA.reportPublic FDA data

Application 021395

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SPIRIVATIOTROPIUM BROMIDEPOWDER;INHALATIONEQ 0.018MG BASE/INHYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0597-0075SpirivaTIOTROPIUM BROMIDEBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0075SpirivaTIOTROPIUM BROMIDEBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0075SpirivaTIOTROPIUM BROMIDEBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
50090-4248SpirivaTIOTROPIUM BROMIDEA-S Medication SolutionsNDACurrent
50090-4414SpirivaTIOTROPIUM BROMIDEA-S Medication SolutionsNDACurrent
50090-4414SpirivaTIOTROPIUM BROMIDEA-S Medication SolutionsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80802SUPPL 2025-01-02
80801SUPPL 2025-01-02
52280SUPPL2018-02-02
52255SUPPL2018-02-01
5248SUPPL2016-06-24
15360SUPPL2015-12-15
5247SUPPL2015-12-14
42136SUPPL2013-06-03
5246SUPPL2011-08-01
15359SUPPL2011-07-29
27662SUPPL2009-12-24
15358SUPPL2009-12-18
15356SUPPL2009-03-19
5245SUPPL2009-03-19
36814SUPPL2008-11-18
27661SUPPL2008-11-18
27660SUPPL2008-06-25
27659SUPPL2006-12-28
5244SUPPL2006-12-28
15357SUPPL2006-12-14
15355SUPPL2006-12-14
27658SUPPL2006-09-25
36813SUPPL2006-09-21
36812SUPPL2004-08-25
27657SUPPL2004-08-25
23653ORIG2004-07-13
21633ORIG2004-05-06
5243ORIG2004-03-16
15354ORIG2004-03-03