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FDA Drug information

BORTEZOMIB

Read time: 1 mins
Marketing start date: 28 Apr 2024
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Summary of product characteristics


Effective Time

20220505

Version

1

Spl Product Data Elements

BORTEZOMIB BORTEZOMIB BORTEZOMIB BORTEZOMIB MANNITOL

Application Number

ANDA210204

Brand Name

BORTEZOMIB

Generic Name

BORTEZOMIB

Product Ndc

70771-1708

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAVENOUS,SUBCUTANEOUS

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1708-1 Bortezomib for Injection 3.5 mg/vial For Intravenous or Subcutaneous Use One Single-dose Vial Rx only NDC 70771-1708-1 Bortezomib for Injection – Carton label 3.5 mg/vial For Intravenous or Subcutaneous Use Reconstitution Information SUBCUTANEOUS INJECTION ONLY 0.9% NaCl Add 1.4 mL 0.9% Sodium Chloride To make 2.5 mg/mL final concentration INTRAVENOUS INJECTION ONLY 0.9% NaCl Add 3.5 mL 0.9% Sodium Chloride To make 1 mg/mL final concentration One Single-dose Vial Rx only Reconstitution Information – Inside Flap (All cartons) SUBCUTANEOUS INJECTION ONLY 0.9% NaCl Add 1.4 mL 0.9% Sodium Chloride To make 2.5 mg/mL final concentration INTRAVENOUS INJECTION ONLY 0.9% NaCl Add 3.5 mL 0.9% Sodium Chloride To make 1 mg/mL final concentration vial label carton label Inside Flap image

Spl Unclassified Section

SPL UNCLASSIFIED

Drug section

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