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FDA Approval

PERJETA

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

FDA Approval Summary

Company
Genentech, Inc.
DUNS: 080129000
Effective Date
October 20, 2020
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Pertuzumab(30 mg in 1 mL)

Registrants1

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

Roche Diagnostics GmbH

315028860

Manufacturing Establishments8

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

F. Hoffmann-La Roche Ltd

Genentech, Inc.

485244961

Roche Singapore Technical Operations Pte. Ltd.

Genentech, Inc.

937189173

Roche Diagnostics GmbH

Genentech, Inc.

Roche Diagnostics GmbH

315028860

Genentech, Inc.

Genentech, Inc.

Roche Diagnostics GmbH

080129000

F. Hoffmann-La Roche Ltd.

Genentech, Inc.

Roche Diagnostics GmbH

485244961

Roche Diagnostics

Genentech, Inc.

Roche Diagnostics GmbH

323105205

Genentech, Inc. (Hillsboro)

Genentech, Inc.

Roche Diagnostics GmbH

833220176

Genentech, Inc. (Oceanside)

Genentech, Inc.

Roche Diagnostics GmbH

146373191

Products1

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

PERJETA

Product Details

NDC Product Code
50242-145
Application Number
BLA125409
Marketing Category
BLA (C73585)
Route of Administration
INTRAVENOUS
Effective Date
October 20, 2020
HISTIDINEInactive
Code: 4QD397987EClass: IACT
Code: K16AIQ8CTMClass: ACTIBQuantity: 30 mg in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YHClass: IACT
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