Arsenic Trioxide

ARSENIC TRIOXIDE- arsenic trioxide injection, solution
Cadila Healthcare Limited

PRINCIPAL DISPLAY PANEL — Vial Label

NDC 49315-007-01

Arsenic Trioxide Injection

12 mg/6 mL

(2 mg/mL)

NEW CONCENTRATION

For Intravenous Use Only

Cytotoxic Agent

6 mL Single-Dose Vial

Rx only

Zydus Pharmaceuticals

vial label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — Carton Label

NDC 49315-007-10

Arsenic Trioxide Injection

12 mg/6 mL

(2 mg/mL)

NEW CONCENTRATION

For Intravenous Use Only

10 X 6 mL Single-Dose Vials

Rx only

Zydus Pharmaceuticals

carton label
(click image for full-size original)
ARSENIC TRIOXIDE
arsenic trioxide injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49315-007
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARSENIC TRIOXIDE (ARSENIC CATION (3+)) ARSENIC TRIOXIDE 2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49315-007-10 10 VIAL in 1 CARTON contains a VIAL (49315-007-01)
1 NDC:49315-007-01 6 mL in 1 VIAL This package is contained within the CARTON (49315-007-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206228 09/03/2019
Labeler — Cadila Healthcare Limited (650348852)
Registrant — Cadila Healthcare Limited (650348852)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 650348852 ANALYSIS (49315-007), MANUFACTURE (49315-007)

Revised: 10/2020 Cadila Healthcare Limited

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