FDA.reportPublic FDA data

Application 761074

Type
BLA
Sponsor
MYLAN GMBH

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761074Ogivritrastuzumab-dkst351(k) BiosimilarRx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OGIVRITRASTUZUMAB-DKSTINJECTABLE;INJECTION420MG/VIALYesNo

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OGIVRITRASTUZUMAB-DKSTBiocon Biologics Inc.b6465b44-a6dd-f99c-d009-6851cf05169c2024-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761074

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67457-845OGIVRItrastuzumabMylan Institutional LLCBLACurrent
67457-845OGIVRItrastuzumabMylan Institutional LLCBLACurrent
67457-847OGIVRItrastuzumabMylan Institutional LLCBLACurrent
67457-847OGIVRItrastuzumabMylan Institutional LLCBLACurrent
67457-847OGIVRItrastuzumabMylan Institutional LLCBLACurrent
67457-847OGIVRItrastuzumabMylan Institutional LLCBLACurrent
67457-847OGIVRItrastuzumabMylan Institutional LLCBLACurrent
67457-847OGIVRItrastuzumabMylan Institutional LLCBLACurrent
67457-847OGIVRItrastuzumabMylan Institutional LLCBLACurrent
67457-847OGIVRItrastuzumabMylan Institutional LLCBLACurrent
67457-847OGIVRItrastuzumabMylan Institutional LLCBLACurrent
67457-847OGIVRItrastuzumabMylan Institutional LLCBLACurrent
67457-991OGIVRItrastuzumabMylan Institutional LLCBLACurrent
67457-991OGIVRItrastuzumabMylan Institutional LLCBLACurrent
67457-991OGIVRItrastuzumabMylan Institutional LLCBLACurrent
67457-991OGIVRItrastuzumabMylan Institutional LLCBLACurrent
67457-991OGIVRItrastuzumabMylan Institutional LLCBLACurrent
67457-991OGIVRItrastuzumabMylan Institutional LLCBLACurrent
67457-991OGIVRItrastuzumabMylan Institutional LLCBLACurrent
67457-991OGIVRItrastuzumabMylan Institutional LLCBLACurrent
67457-991OGIVRItrastuzumabMylan Institutional LLCBLACurrent
67457-991OGIVRItrastuzumabMylan Institutional LLCBLACurrent
67457-991OGIVRItrastuzumabMylan Institutional LLCBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80217SUPPL 2024-11-14
80210SUPPL 2024-11-14
75669SUPPL 2023-10-03
75666SUPPL 2023-10-03
59232SUPPL2019-07-03
58367SUPPL2019-04-23
50582ORIG2019-01-30
56585ORIG2018-11-29
50536ORIG2017-12-01