Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Gland Pharma Limited
918601238
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
GLAND PHARMA LIMITED
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Gland Pharma Limited
858971074
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ONDANSETRON
Product Details
NDC Product Code
23155-549Application Number
ANDA090648Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUS, INTRAMUSCULAREffective Date
March 4, 2022OndansetronActive
Code: NMH84OZK2BClass: ACTIMQuantity: 2 mg in 1 mL
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACTQuantity: 0.5 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 8.3 mg in 1 mL
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACTQuantity: 1.2 mg in 1 mL
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACTQuantity: 0.15 mg in 1 mL
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACTQuantity: 0.25 mg in 1 mL
ONDANSETRON
Product Details
NDC Product Code
23155-547Application Number
ANDA079224Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUS, INTRAMUSCULAREffective Date
March 4, 2022CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACTQuantity: 0.5 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9.0 mg in 1 mL
OndansetronActive
Code: NMH84OZK2BClass: ACTIMQuantity: 2 mg in 1 mL
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACTQuantity: 0.25 mg in 1 mL