Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Samsung Bioepis Co., Ltd.
557822226
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ontruzant
Product Details
NDC Product Code
78206-147Application Number
BLA761100Marketing Category
BLA (C73585)Route of Administration
INTRAVENOUSEffective Date
January 31, 2023TrastuzumabActive
Code: P188ANX8CKClass: ACTIBQuantity: 150 mg in 1 1
histidine monohydrochloride monohydrateInactive
Code: X573657P6PClass: IACTQuantity: 3.4 mg in 1 1
histidineInactive
Code: 4QD397987EClass: IACTQuantity: 2.2 mg in 1 1
polysorbate 20Inactive
Code: 7T1F30V5YHClass: IACTQuantity: 0.6 mg in 1 1
trehalose dihydrateInactive
Code: 7YIN7J07X4Class: IACTQuantity: 136.2 mg in 1 1
Ontruzant
Product Details
NDC Product Code
78206-148Application Number
BLA761100Marketing Category
BLA (C73585)Route of Administration
INTRAVENOUSEffective Date
January 31, 2023Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
BOXED WARNING SECTION
**WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and
PULMONARY TOXICITY**