FDA.reportPublic FDA data

Application 021730

Type
NDA
Sponsor
SUNOVION

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XOPENEX HFALEVALBUTEROL TARTRATEAEROSOL, METERED;INHALATIONEQ 0.045MG BASE/INHYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-2927Levalbuterol tartrate HFA inhalationlevalbuterol tartrateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2927Levalbuterol tartrate HFA inhalationlevalbuterol tartrateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2927Levalbuterol tartrate HFA inhalationlevalbuterol tartrateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
63187-876Levalbuterol tartrate HFA inhalationlevalbuterol tartrateProficient Rx LPNDA AUTHORIZED GENERICCurrent
63187-876Levalbuterol tartrate HFA inhalationlevalbuterol tartrateProficient Rx LPNDA AUTHORIZED GENERICCurrent
63187-876Levalbuterol tartrate HFA inhalationlevalbuterol tartrateProficient Rx LPNDA AUTHORIZED GENERICCurrent
63402-510Xopenex HFAlevalbuterol tartrateSunovion Pharmaceuticals Inc.NDACurrent
63402-510Xopenex HFAlevalbuterol tartrateSunovion Pharmaceuticals NDACurrent
63402-510Xopenex HFAlevalbuterol tartrateSunovion Pharmaceuticals Inc.NDACurrent
63402-510Xopenex HFAlevalbuterol tartrateSunovion Pharmaceuticals Inc.NDACurrent
63629-8822Levalbuterol tartrate HFA inhalationlevalbuterol tartrateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-8822Levalbuterol tartrate HFA inhalationlevalbuterol tartrateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
68788-6845Levalbuterol tartrate HFA inhalationlevalbuterol tartratePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
68788-6845Levalbuterol tartrate HFA inhalationlevalbuterol tartratePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47370SUPPL2017-02-28
16274SUPPL2015-03-17
28486SUPPL2015-03-13
6075SUPPL2013-09-12
16273SUPPL2013-09-11
6074SUPPL2012-08-01
37547SUPPL2012-07-30
16272SUPPL2008-02-14
6073SUPPL2008-02-07
21795ORIG2006-12-13
28484SUPPL2006-09-20
28485SUPPL2006-04-07
37546ORIG2005-03-14
6072ORIG2005-03-14
51293SUPPL1900-01-01
51292SUPPL1900-01-01
51291SUPPL1900-01-01