Manufacturing Establishments4
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Boehringer Ingelheim Pharma GmbH and Co. KG
Pfizer Laboratories Div Pfizer Inc
340700520
Pfizer Ireland Pharmaceuticals
Pfizer Laboratories Div Pfizer Inc
985586408
Pfizer Manufacturing Belgium NV
Pfizer Laboratories Div Pfizer Inc
370156507
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC
Pfizer Laboratories Div Pfizer Inc
174350868
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Trazimera
Product Details
NDC Product Code
0069-0305Application Number
BLA761081Marketing Category
BLA (C73585)Effective Date
February 14, 2022Trazimera
Product Details
NDC Product Code
0069-0308Application Number
BLA761081Marketing Category
BLA (C73585)Route of Administration
INTRAVENOUSEffective Date
February 14, 2022TrastuzumabActive
Code: P188ANX8CKClass: ACTIBQuantity: 150 mg in 7.15 mL
HISTIDINEInactive
Code: 4QD397987EClass: IACTQuantity: 2.8 mg in 7.15 mL
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Code: X573657P6PClass: IACTQuantity: 3.4 mg in 7.15 mL
SUCROSEInactive
Code: C151H8M554Class: IACTQuantity: 138 mg in 7.15 mL
POLYSORBATE 20Inactive
Code: 7T1F30V5YHClass: IACTQuantity: 0.6 mg in 7.15 mL