FDA.reportPublic FDA data

Application 022007

Type
NDA
Sponsor
MYLAN SPECLT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PERFOROMISTFORMOTEROL FUMARATESOLUTION;INHALATION0.02MG/2MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-1631FORMOTEROL FUMARATEformoterol fumarate dihydrateMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-1631FORMOTEROL FUMARATEformoterol fumarate dihydrateMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-1631FORMOTEROL FUMARATEformoterol fumarate dihydrateMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-1631FORMOTEROL FUMARATEformoterol fumarate dihydrateMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
49502-605Perforomistformoterol fumarate dihydrateMylan Specialty L.P.NDACurrent
49502-605Perforomistformoterol fumarate dihydrateMylan Specialty L.P.NDACurrent
49502-605Perforomistformoterol fumarate dihydrateMylan Specialty L.P.NDACurrent
49502-605Perforomistformoterol fumarate dihydrateMylan Specialty L.P.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58958SUPPL2019-06-04
58897SUPPL2019-05-31
56133SUPPL2018-10-29
56132SUPPL2018-10-29
56057SUPPL2018-10-23
50571SUPPL2017-12-01
50550SUPPL2017-12-01
29058SUPPL2012-10-02
6670SUPPL2012-10-02
38072SUPPL2012-01-23
29057SUPPL2012-01-17
29056SUPPL2011-02-07
23338ORIG2010-06-04
29055SUPPL2010-06-03
38071SUPPL2010-06-02
21902ORIG2009-03-19
44167ORIG2008-04-01
16752ORIG2008-03-28
29054ORIG2007-05-31
6669ORIG2007-05-01