Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Fresenius Kabi USA, LLC
Fresenius Kabi USA, LLC
840771732
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Granisetron
Product Details
NDC Product Code
63323-317Application Number
ANDA078522Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
July 31, 2022SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACTQuantity: 2.12 mg in 1 mL
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACTQuantity: 0.67 mg in 1 mL
GranisetronActive
Code: 318F6L70J8Class: ACTIMQuantity: 0.1 mg in 1 mL
Granisetron
Product Details
NDC Product Code
63323-319Application Number
ANDA078090Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
July 31, 2022SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACTQuantity: 0.67 mg in 1 mL
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACTQuantity: 2.12 mg in 1 mL
PHENOLInactive
Code: 339NCG44TVClass: IACTQuantity: 5 mg in 1 mL
GranisetronActive
Code: 318F6L70J8Class: ACTIMQuantity: 1 mg in 1 mL
Granisetron
Product Details
NDC Product Code
63323-318Application Number
ANDA078096Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
July 31, 2022CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACTQuantity: 0.67 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACTQuantity: 2.12 mg in 1 mL
GranisetronActive
Code: 318F6L70J8Class: ACTIMQuantity: 1 mg in 1 mL