FDA.reportPublic FDA data

Application 021912

Type
NDA
Sponsor
SUNOVION

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BROVANAARFORMOTEROL TARTRATESOLUTION;INHALATIONEQ 0.015MG BASE/2MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63402-911Brovanaarformoterol tartrateSunovion Pharmaceuticals Inc.NDACurrent
63402-911Brovanaarformoterol tartrateSunovion Pharmaceuticals Inc.NDACurrent
63402-911Brovanaarformoterol tartrateSunovion Pharmaceuticals Inc.NDACurrent
63402-911Brovanaarformoterol tartrateSunovion Pharmaceuticals Inc.NDACurrent
63402-911Brovanaarformoterol tartrateSunovion Pharmaceuticals Inc.NDACurrent
70748-257Arformoterol TartrateArformoterol TartrateLupin Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58962SUPPL2019-06-04
58896SUPPL2019-05-31
56236SUPPL2018-11-01
37872SUPPL2014-03-04
6444SUPPL2014-03-04
28840SUPPL2012-08-13
6443SUPPL2012-08-13
6442SUPPL2011-09-07
37871SUPPL2011-07-18
28838SUPPL2011-07-18
16567SUPPL2011-02-24
28839SUPPL2011-02-18
6441SUPPL2011-02-07
6440SUPPL2010-06-03
16566SUPPL2010-06-02
24227ORIG2009-04-14
21869ORIG2009-04-14
28837SUPPL2008-01-09
37870SUPPL2008-01-08
44160ORIG2007-02-20
28836ORIG2006-10-13
16565ORIG2006-10-11