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

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

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