Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
ETOPOSIDE (UNII: 6PLQ3CP4P3) (ETOPOSIDE - UNII:6PLQ3CP4P3)
ThyMoorgan GmbH Pharmazir & Co. K.G
ETOPOSIDE
ETOPOSIDE 20 mg in 1 mL
PRESCRIPTION DRUG
APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT
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 Læs hele dokumentet