FDA.reportPublic FDA data

Application 021949

Type
NDA
Sponsor
ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PULMICORT FLEXHALERBUDESONIDEPOWDER, METERED;INHALATION0.08MG/INHYesNo
002PULMICORT FLEXHALERBUDESONIDEPOWDER, METERED;INHALATION0.16MG/INHYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0186-0916PULMICORTBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
0186-0916PULMICORTBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
0186-0916PULMICORTBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
0186-0916PULMICORTBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
0186-0916PULMICORTBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
0186-0916PULMICORTBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
0186-0917PULMICORTBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
0186-0917PULMICORTBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
0186-0917PULMICORTBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
0186-0917PULMICORTBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
0186-0917PULMICORTBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
0186-0917PULMICORTBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
21695-291PULMICORTBudesonideRebel Distributors CorpNDACurrent
50090-2239PULMICORTBudesonideA-S Medication SolutionsNDACurrent
50090-2239PULMICORTBudesonideA-S Medication SolutionsNDACurrent
50090-2239PULMICORTBudesonideA-S Medication SolutionsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59949SUPPL2019-09-10
59939SUPPL2019-09-09
6528SUPPL2010-07-08
16633SUPPL2010-07-06
42356ORIG2008-11-17
6527SUPPL2008-06-19
37940SUPPL2008-06-18
16632SUPPL2008-04-16
6526SUPPL2008-04-16
6525SUPPL2007-07-05
16631SUPPL2007-06-27
16630SUPPL2007-02-23
6524SUPPL2007-02-23
6523ORIG2006-07-21
37939ORIG2006-07-13