MedPath
FDA Approval

Ondansetron

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
January 21, 2014
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Ondansetron(8 mg in 1 1)

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
33261-761
Application Number
ANDA078152
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 21, 2014
Code: 4AF302ESOSClass: ACTIBQuantity: 8 mg in 1 1
ASPARTAMEInactive
Code: Z0H242BBR1Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT

Ondansetron

Product Details

NDC Product Code
33261-747
Application Number
ANDA078152
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 21, 2014
Code: 4AF302ESOSClass: ACTIBQuantity: 4 mg in 1 1
ASPARTAMEInactive
Code: Z0H242BBR1Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
© Copyright 2025. All Rights Reserved by MedPath