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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077557
Company: SUN PHARM INDS
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
08/02/2007 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
03/14/2018 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

03/24/2017 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

03/24/2017 SUPPL-13 Labeling

Label is not available on this site.

02/28/2016 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

10/07/2013 SUPPL-7 Labeling-Container/Carton Labels

Label is not available on this site.

04/26/2013 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

06/18/2008 SUPPL-2 Labeling

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 077406 CHARTWELL MOLECULES
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

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 077406 CHARTWELL MOLECULES
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
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