Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078050
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ONDANSETRON ONDANSETRON 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
ONDANSETRON ONDANSETRON 8MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/13/2007 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/14/2018 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

03/24/2017 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

12/10/2014 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

12/10/2014 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

02/16/2012 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

10/18/2011 SUPPL-4 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

03/31/2011 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

10/29/2010 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

ONDANSETRON

TABLET, ORALLY DISINTEGRATING;ORAL; 4MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ONDANSETRON ONDANSETRON 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090469 AUROBINDO PHARMA
ONDANSETRON ONDANSETRON 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 076693 BARR
ONDANSETRON ONDANSETRON 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078152 GLENMARK GENERICS
ONDANSETRON ONDANSETRON 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078139 MYLAN
ONDANSETRON ONDANSETRON 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078050 SANDOZ
ONDANSETRON ONDANSETRON 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077557 SUN PHARM INDS
ONDANSETRON ONDANSETRON 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078602 SUN PHARM INDS LTD
ONDANSETRON ONDANSETRON 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 076810 TEVA
ZOFRAN ODT ONDANSETRON 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 020781 NOVARTIS

TABLET, ORALLY DISINTEGRATING;ORAL; 8MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ONDANSETRON ONDANSETRON 8MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090469 AUROBINDO PHARMA
ONDANSETRON ONDANSETRON 8MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 076693 BARR
ONDANSETRON ONDANSETRON 8MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078152 GLENMARK GENERICS
ONDANSETRON ONDANSETRON 8MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078139 MYLAN
ONDANSETRON ONDANSETRON 8MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078050 SANDOZ
ONDANSETRON ONDANSETRON 8MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077557 SUN PHARM INDS
ONDANSETRON ONDANSETRON 8MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078602 SUN PHARM INDS LTD
ONDANSETRON ONDANSETRON 8MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 076810 TEVA
ZOFRAN ODT ONDANSETRON 8MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 020781 NOVARTIS

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