ARSENIC TRIOXIDE - arsenic trioxide injection, solution 
Zydus Lifesciences Limited

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ARSENIC TRIOXIDE INJECTION

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

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
ARSENIC TRIOXIDE 
arsenic trioxide injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49315-007
Route of Administration INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 2 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49315-007-10 10 in 1 CARTON 09/03/2019
1 NDC:49315-007-01 6 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206228 09/03/2019
Labeler - Zydus Lifesciences Limited (650348852)
Registrant - Zydus Lifesciences Limited (650348852)
Establishment
Name Address ID/FEI Business Operations
Zydus Lifesciences Limited 650348852 ANALYSIS(49315-007) , MANUFACTURE(49315-007)

Revised: 11/2022
Document Id: e80b0973-e6e5-4914-b5f0-4528d7fa7285
Set id: 2ad7bb19-6152-4158-a179-2388e86a981f
Version: 3
Effective Time: 20221105
 
Zydus Lifesciences Limited