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Application 021747

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001COMBIVENT RESPIMATALBUTEROL SULFATE; IPRATROPIUM BROMIDESPRAY, METERED;INHALATIONEQ 0.1MG BASE/INH;0.02MG/INHYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0597-0024Combivent Respimatipratropium bromide and albuterolBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0024Combivent Respimatipratropium bromide and albuterolBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0024Combivent Respimatipratropium bromide and albuterolBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0024Combivent Respimatipratropium bromide and albuterolBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0024Combivent Respimatipratropium bromide and albuterolBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0024Combivent Respimatipratropium bromide and albuterolBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64747SUPPL2020-09-29
64728SUPPL2020-09-29
16301SUPPL2016-06-13
6109SUPPL2016-06-10
16300SUPPL2016-02-25
6108SUPPL2016-02-01
28512SUPPL2014-10-22
16299SUPPL2014-10-21
37574SUPPL2012-08-31
28511SUPPL2012-08-31
42296ORIG2012-08-16
24215ORIG2012-08-16
28510ORIG2011-10-12
16298ORIG2011-10-12