Application 761125

Type
BLA
Sponsor
NOVARTIS PHARMS CORP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BEOVUbrolucizumab-dbllINJECTABLE; INTRAVITREAL6MG/0.05MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0827BEOVUbrolucizumabNovartis Pharmaceuticals CorporationBLACurrent
0078-0827BEOVUbrolucizumabNovartis Pharmaceuticals CorporationBLACurrent
0078-0827BEOVUbrolucizumabNovartis Pharmaceuticals CorporationBLACurrent
0078-0827BEOVUbrolucizumabNovartis Pharmaceuticals CorporationBLACurrent
0078-0827BEOVUbrolucizumabNovartis Pharmaceuticals CorporationBLACurrent
0078-0827BEOVUbrolucizumabNovartis Pharmaceuticals CorporationBLACurrent
0078-0827BEOVUbrolucizumabNovartis Pharmaceuticals CorporationBLACurrent
0078-0827BEOVUbrolucizumabNovartis Pharmaceuticals CorporationBLACurrent
0078-0827BEOVUbrolucizumabNovartis Pharmaceuticals CorporationBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79254SUPPL 2024-07-30
79250SUPPL 2024-07-30
75619SUPPL 2023-09-29
75609SUPPL 2023-09-29
72982SUPPL2022-12-21
72963SUPPL2022-12-21
71178SUPPL2022-05-31
71173SUPPL2022-05-31
70208SUPPL2022-02-22
70207SUPPL2022-02-22
70206SUPPL2022-02-22
70201SUPPL2022-02-22
70200SUPPL2022-02-22
70199SUPPL2022-02-22
64843SUPPL2020-10-06
63532SUPPL2020-06-12
63474SUPPL2020-06-10
60777ORIG2019-11-04
60409ORIG2019-10-09
60338ORIG2019-10-08