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FDA Approval

HERZUMA

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Cephalon, Inc.
DUNS: 183236314
Effective Date
February 6, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Trastuzumab(150 mg in 7.15 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

CELLTRION, Inc.

688836030

Manufacturing Establishments7

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Andersonbrecon Limited

Cephalon, Inc.

CELLTRION, Inc.

762771269

WuXi AppTec, Inc.

Cephalon, Inc.

CELLTRION, Inc.

053506585

SGS Vitrology Limited

Cephalon, Inc.

CELLTRION, Inc.

516257446

BioReliance Ltd.

Cephalon, Inc.

CELLTRION, Inc.

217063514

Andersonbrecon Inc.

Cephalon, Inc.

CELLTRION, Inc.

053217022

CELLTRION, Inc.

Cephalon, Inc.

CELLTRION, Inc.

688836030

WuXi Advanced Therapies Inc.

Cephalon, Inc.

CELLTRION, Inc.

117556312

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

HERZUMA

Product Details

NDC Product Code
63459-303
Application Number
BLA761091
Marketing Category
BLA (C73585)
Route of Administration
INTRAVENOUS
Effective Date
February 6, 2023
Code: P188ANX8CKClass: ACTIBQuantity: 150 mg in 7.15 mL
TREHALOSE DIHYDRATEInactive
Code: 7YIN7J07X4Class: IACTQuantity: 299.6 mg in 7.15 mL
HISTIDINEInactive
Code: 4QD397987EClass: IACTQuantity: 2.2 mg in 7.15 mL
POLYSORBATE 20Inactive
Code: 7T1F30V5YHClass: IACTQuantity: 0.6 mg in 7.15 mL
HISTIDINE MONOHYDROCHLORIDEInactive
Code: 1D5Q932XM6Class: IACTQuantity: 3.4 mg in 7.15 mL

HERZUMA

Product Details

NDC Product Code
63459-305
Application Number
BLA761091
Marketing Category
BLA (C73585)
Effective Date
February 6, 2023

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

INDICATIONS & USAGE SECTION

DOSAGE & ADMINISTRATION SECTION


DRUG INTERACTIONS SECTION


NONCLINICAL TOXICOLOGY SECTION


INFORMATION FOR PATIENTS SECTION


SPL UNCLASSIFIED SECTION


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