DECITABINE injection, powder, lyophilized, for solution

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

DECITABINE (UNII: 776B62CQ27) (DECITABINE - UNII:776B62CQ27)

可用日期:

Zydus Lifesciences Limited

给药途径:

INTRAVENOUS

处方类型:

PRESCRIPTION DRUG

授权状态:

Abbreviated New Drug Application

产品特点

DECITABINE - DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
ZYDUS LIFESCIENCES LIMITED
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DECITABINE FOR INJECTION, FOR INTRAVENOUS USE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1713-1
Decitabine for Injection
50 mg per vial
FOR INTRAVENOUS INFUSION ONLY
WARNING: Cytotoxic Agent
Single-Dose Sterile Vial – Discard unused portion.
Rx only
NDC 70771-1713-1
Decitabine for Injection
50 mg per vial
FOR INTRAVENOUS INFUSION ONLY
WARNING: Cytotoxic Agent
Single-Dose Sterile Vial – Discard unused portion.
Rx only
DECITABINE
decitabine injection, powder, lyophilized, for solution
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1713
ROUTE OF ADMINISTRATION
INTRAVENOUS
Zydus Lifesciences Limited
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
DECITABINE (UNII: 776B62CQ27) (DECITABINE - UNII:776B62CQ27)
DECITABINE
50 mg in 20 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1713-1
1 in 1 CARTON
05/11/2023
1
20 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
ANDA214486
05/11/2023
LABELER -
Zydus Lifesciences Limited (918596198)
REGISTRANT -
Zydus Pharmaceuticals USA Inc. (156861945)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Zydus Hospira Oncology
Private Limited
676190889
ANALYSIS(70771-1713) , LABEL(70771-1713) ,
MANUFACTURE(70771-1713) , PACK(70771-1713)
Revised: 10/2022