FDA.reportPublic FDA data

Application 212122

Type
NDA
Sponsor
ASTRAZENECA AB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BREZTRI AEROSPHEREBUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATEAEROSOL, METERED;INHALATION160MCG/INH; 4.8 MCG/INH; 9MCG/INHYesNo
002BREZTRI AEROSPHEREBUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATEAEROSOL, METERED;INHALATION0.16MG/INH;0.0048MG/INH;0.018MG/INHYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0310-4616BREZTRIbudesonide, glycopyrrolate, and formoterol fumarateAstraZeneca Pharmaceuticals LPNDACurrent
0310-4616BREZTRIbudesonide, glycopyrrolate, and formoterol fumarateAstraZeneca Pharmaceuticals LPNDACurrent
0310-4616BRETZRIbudesonide, glycopyrrolate, and formoterol fumarateAstraZeneca Pharmaceuticals LPNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85788SUPPL 2026-05-01
85787SUPPL 2026-05-01
73957SUPPL 2023-04-06
68008ORIG2021-07-01
64099ORIG2020-07-27
64091ORIG2020-07-24