FDA.reportPublic FDA data

Application 021527

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATROVENT HFAIPRATROPIUM BROMIDEAEROSOL, METERED;INHALATION0.021MG/INHYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0597-0087Atroventipratropium bromideBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0087Atroventipratropium bromideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0087Atroventipratropium bromideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0087Atroventipratropium bromideBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0087Atroventipratropium bromideBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
50090-0961Atroventipratropium bromideA-S Medication SolutionsNDACurrent
53002-8410Atroventipratropium bromideRPK Pharmaceuticals, Inc.NDACurrent
53002-8410Atroventipratropium bromideRPK Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80800SUPPL 2025-01-02
80799SUPPL 2025-01-02
68306SUPPL2021-08-06
61568SUPPL2020-01-14
61563SUPPL2020-01-14
15693SUPPL2012-08-31
5647SUPPL2012-08-31
37158SUPPL2011-10-12
28031SUPPL2011-10-12
5646SUPPL2010-12-28
15692SUPPL2010-12-26
28030SUPPL2008-10-22
21718ORIG2007-01-23
15691SUPPL2006-09-15
5645SUPPL2006-09-15
28029SUPPL2006-04-05
15690ORIG2004-12-03
5644ORIG2004-12-02