Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
NELARABINE (UNII: 60158CV180) (NELARABINE - UNII:60158CV180)
Zydus Lifesciences Limited
INTRAVENOUS
PRESCRIPTION DRUG
Abbreviated New Drug Application
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 Прочетете целия документ