Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Granisetron Hydrochloride
Product Details
NDC Product Code
67457-864Application Number
ANDA091137Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
August 31, 2017GranisetronActive
Code: 318F6L70J8Class: ACTIMQuantity: 1 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
Granisetron Hydrochloride
Product Details
NDC Product Code
67457-863Application Number
ANDA091136Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
August 31, 2017GranisetronActive
Code: 318F6L70J8Class: ACTIMQuantity: 1 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
Granisetron Hydrochloride
Product Details
NDC Product Code
67457-861Application Number
ANDA091136Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
August 31, 2017ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
GranisetronActive
Code: 318F6L70J8Class: ACTIMQuantity: 0.1 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT