FDA.reportPublic FDA data

Application 021929

Type
NDA
Sponsor
ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SYMBICORTBUDESONIDE; FORMOTEROL FUMARATE DIHYDRATEAEROSOL, METERED;INHALATION0.08MG/INH;0.0045MG/INHYesYes
002SYMBICORTBUDESONIDE; FORMOTEROL FUMARATE DIHYDRATEAEROSOL, METERED;INHALATION0.16MG/INH;0.0045MG/INHYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0186-0370SYMBICORTBudesonide and Formoterol Fumarate DihydrateAstraZeneca Pharmaceuticals LPNDACurrent
0186-0370SYMBICORTBudesonide and Formoterol Fumarate DihydrateAstraZeneca Pharmaceuticals LPNDACurrent
0186-0370SYMBICORTBudesonide and Formoterol Fumarate DihydrateAstraZeneca Pharmaceuticals LPNDACurrent
0186-0372SYMBICORTBudesonide and Formoterol Fumarate DihydrateAstraZeneca Pharmaceuticals LPNDACurrent
0186-0372SYMBICORTBudesonide and Formoterol Fumarate DihydrateAstraZeneca Pharmaceuticals LPNDACurrent
0186-0372SYMBICORTBudesonide and Formoterol Fumarate DihydrateAstraZeneca Pharmaceuticals LPNDACurrent
0310-7370Budesonide and Formoterol Fumarate DihydrateBudesonide and Formoterol Fumarate DihydrateAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0310-7370Budesonide and Formoterol Fumarate DihydrateBudesonide and Formoterol Fumarate DihydrateAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0310-7370Budesonide and Formoterol Fumarate DihydrateBudesonide and Formoterol Fumarate DihydrateAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0310-7372Budesonide and Formoterol Fumarate DihydrateBudesonide and Formoterol Fumarate DihydrateAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0310-7372Budesonide and Formoterol Fumarate DihydrateBudesonide and Formoterol Fumarate DihydrateAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0310-7372Budesonide and Formoterol Fumarate DihydrateBudesonide and Formoterol Fumarate DihydrateAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
50090-1403SYMBICORTBudesonide and Formoterol Fumarate DihydrateA-S Medication SolutionsNDACurrent
53002-2666Budesonide and Formoterol Fumarate DihydrateBudesonide and Formoterol Fumarate DihydrateRPK Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
53002-2667Budesonide and Formoterol Fumarate DihydrateBudesonide and Formoterol Fumarate DihydrateRPK Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
70518-2696SYMBICORTBudesonide and Formoterol Fumarate DihydrateREMEDYREPACK INC.NDACurrent
70518-3107Budesonide and Formoterol Fumarate DihydrateBudesonide and Formoterol Fumarate DihydrateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-3107Budesonide and Formoterol Fumarate DihydrateBudesonide and Formoterol Fumarate DihydrateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-3107Budesonide and Formoterol Fumarate DihydrateBudesonide and Formoterol Fumarate DihydrateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-3107Budesonide and Formoterol Fumarate DihydrateBudesonide and Formoterol Fumarate DihydrateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50926SUPPL2017-12-27
50829SUPPL2017-12-21
49749SUPPL2017-09-15
49721SUPPL2017-09-12
49720SUPPL2017-09-12
47047SUPPL2017-01-31
47032SUPPL2017-01-27
51270SUPPL2015-10-19
51269SUPPL2015-03-09
28877SUPPL2012-07-25
51268SUPPL2012-04-06
42353SUPPL2012-03-02
6488SUPPL2011-08-22
51267SUPPL2011-05-05
28875SUPPL2011-02-18
51266SUPPL2011-01-28
28876SUPPL2010-06-29
16601SUPPL2010-06-28
16600SUPPL2009-04-03
6487SUPPL2009-03-03
42352ORIG2008-10-30
28874SUPPL2008-07-17
16599SUPPL2008-07-16
28873SUPPL2007-11-08
6486SUPPL2007-11-08
37905SUPPL2007-11-07
16598SUPPL2007-11-07
23686ORIG2007-02-21
37904ORIG2006-07-21
6485ORIG2006-07-21
52069SUPPL1900-01-01
52067SUPPL1900-01-01
52065SUPPL1900-01-01