NELARABINE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NELARABINE (UNII: 60158CV180) (NELARABINE - UNII:60158CV180)

Available from:

Zydus Lifesciences Limited

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NELARABINE - NELARABINE INJECTION
ZYDUS LIFESCIENCES LIMITED
----------
NELARABINE INJECTION
.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1685-1
Nelarabine Injection 250 mg/5 mL (5 mg/mL)
50 mL Single-Dose Vial
For Intravenous Infusion Only
Rx Only
NDC 70771-1685-1
Nelarabine Injection 250 mg/5 mL (5 mg/mL)
50 mL Single-Dose Vial Carton
For Intravenous Infusion Only
Rx Only
NELARABINE
nelarabine injection
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1685
ROUTE OF ADMINISTRATION
INTRAVENOUS
Zydus Lifesciences Limited
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
NELARABINE (UNII: 60158CV180) (NELARABINE - UNII:60158CV180)
NELARABINE
5 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1685-1
1 in 1 CARTON
11/17/2021
1
50 mL in 1 VIAL; Type 0: Not a Combination
Product
2
NDC:70771-
1685-8
6 in 1 CARTON
11/17/2021
2
50 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
ANDA215037
11/17/2021
LABELER -
Zydus Lifesciences Limited (918596198)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Zydus Lifesciences Limited
650348852
ANALYSIS(70771-1685) , MANUFACTURE(70771-1685)
Revised: 11/2022