BORTEZOMIB
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
1 mins
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