NDC Code(s) : 72205-183-01
Packager : Novadoz Pharmaceuticals LLC

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Bortezomib Bortezomib INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:72205-183
Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BORTEZOMIB(UNII: 69G8BD63PP)
(BORTEZOMIB - UNII:69G8BD63PP) 		BORTEZOMIB3.5 mg in 3.5 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL(UNII: 3OWL53L36A)35 mg in 3.5 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72205-183-011 in 1 CARTON 27/07/2022
13.5 mL in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209622 07/26/2022

LABELER - Novadoz Pharmaceuticals LLC(081109687)

Establishment
Name Address ID/FEI Business Operations
MSN LABORATORIES PRIVATE LIMITED 650786952 ANALYSIS(72205-183), MANUFACTURE(72205-183)

PRINCIPAL DISPLAY PANEL

Bortezomib-Carton-ouside-Label
bortezomib-carton-label

Bortezomib-Vial-Label

bortezomib-carton-label
Bortezomib-intravenous-sticker-label
bortezomib-carton-label

Bortezomib-subcutaneous-sticker-label

bortezomib-carton-label