ETOPOSIDE injection

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

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Hent Produktets egenskaber (SPC)
13-05-2018

Aktiv bestanddel:

ETOPOSIDE (UNII: 6PLQ3CP4P3) (ETOPOSIDE - UNII:6PLQ3CP4P3)

Tilgængelig fra:

ThyMoorgan GmbH Pharmazir & Co. K.G

INN (International Name):

ETOPOSIDE

Sammensætning:

ETOPOSIDE 20 mg in 1 mL

Recept type:

PRESCRIPTION DRUG

Autorisation status:

APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT

Produktets egenskaber

                                ETOPOSIDE- ETOPOSIDE INJECTION
THYMOORGAN GMBH PHARMAZIR & CO. K.G
----------
ETOPOSIDE INJECTION, USP
VIAL LABEL - 5 ML
ETOPOSIDE INJECTION, USP 100 MG /5 ML VIAL LABEL IMAG E
NDC 0143-9510-01 Rx only
Etoposide Injection, USP
100 mg/5 mL (20 mg/mL)
Must be diluted before Intravenous Infusion
VIAL LABEL - 25 ML
ETOPOSIDE INJECTION, USP 500 MG /25 ML VIAL LABEL IMAG E
NDC 0143-9511-01 Rx only
Etoposide Injection, USP
500 mg/25 mL (20 mg/mL)
Must be diluted before Intravenous Infusion
VIAL LABEL - 50 ML
ETOPOSIDE INJECTION, USP 1 G /50 ML VIAL LABEL IMAG E
NDC 0143-9512-01 Rx only
Etoposide Injection, USP
1 g/50 mL (20 mg/mL)
Must be diluted before Intravenous Infusion
ETOPOSIDE
etoposide injection
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:426 0 5-0 31
ROUTE OF ADMINISTRATION
INTRAVENOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ETO PO SIDE (UNII: 6 PLQ3CP4P3) (ETOPOSIDE - UNII:6 PLQ3CP4P3)
ETOPOSIDE
20 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
ALCO HO L (UNII: 3K9 9 58 V9 0 M)
0 .30 5 mL in 1 mL
BENZYL ALCO HO L (UNII: LKG8 49 4WBH)
30 mg in 1 mL
CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)
2 mg in 1 mL
PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)
8 0 mg in 1 mL
PO LYETHYLENE GLYCO L 3 0 0 (UNII: 56 55G9 Y8 AQ)
6 50 mg in 1 mL
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:426 0 5-0 31-0 1
1 in 1 BOX, UNIT-DOSE
10 /23/20 17
1
5 mL in 1 VIAL; Type 0 : No t a Co mbinatio n Pro duct
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR
MARKE TING START
MARKE TING END
MARKE TING CATE GORY
MONOGRAPH CITATION
DATE
DATE
APPROVED DRUG PRODUCT MANUFACTURED
UNDER CONTRACT
ANDA0 7429 0
10 /23/20 17
ETOPOSIDE
etoposide injection
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:426 0 5-0 32
ROUTE OF ADMINISTRATION
INTRAVENOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ETO PO SIDE (UNII: 6 PLQ3CP4P3) (ETOPOSIDE - UNII
                                
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