Application 021247

Type
NDA
Sponsor
MYLAN SPECIALITY LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AEROSPAN HFAFLUNISOLIDEAEROSOL, METERED;INHALATION0.078MG/INHYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0037-7590AerospanflunisolideMeda PharmaceuticalsNDACurrent
0037-7590AerospanflunisolideMeda PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
53868SUPPL2018-04-27
53820SUPPL2018-04-26
50492SUPPL2017-11-27
50459SUPPL2017-11-20
48836SUPPL2017-06-27
48834SUPPL2017-06-26
36448SUPPL2013-08-29
27195SUPPL2013-08-29
27194SUPPL2012-11-19
14726SUPPL2012-11-19
42051ORIG2008-12-22
27193ORIG2006-02-02
14725ORIG2006-02-02