Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Aurobindo Pharma Limited
650082092
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Redpharm Drug, INc.
Redpharm Drug, Inc.
Aurobindo Pharma Limited
828374897
Products1
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
67296-1137Application Number
ANDA090469Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 7, 2023CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
ASPARTAMEInactive
Code: Z0H242BBR1Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
OndansetronActive
Code: 4AF302ESOSClass: ACTIBQuantity: 4 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT