FDA.reportPublic FDA data

Application 761070

Type
BLA
Sponsor
ASTRAZENECA AB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FASENRABENRALIZUMABINJECTABLE;INJECTION30MG/MLYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0310-1730FASENRABenralizumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-1730FASENRABenralizumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-1730FASENRABenralizumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-1730FASENRABenralizumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-1730FASENRABenralizumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-1730FASENRABenralizumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-1730FASENRABenralizumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-1730FASENRABenralizumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-1730FASENRABenralizumabAstraZeneca PharmaceuticaBLACurrent
0310-1830FASENRABenralizumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-1830FASENRABenralizumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-1830FASENRABenralizumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-1830FASENRABenralizumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-1830FASENRABenralizumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-1830FASENRABenralizumabAstraZeneca Pharmaceuticals LPBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85942SUPPL 2026-05-18
85920SUPPL 2026-05-15
79659SUPPL 2024-09-19
79652SUPPL 2024-09-18
78078SUPPL 2024-04-09
78082SUPPL 2024-04-08
60244SUPPL2019-10-04
60222SUPPL2019-10-04
50943ORIG2017-12-29
50424ORIG2017-11-15
50414ORIG2017-11-15
51890ORIG1900-01-01
51889ORIG1900-01-01
51888ORIG1900-01-01