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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090469
Company: AUROBINDO PHARMA
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 Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/12/2010 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
01/31/2024 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

01/31/2024 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

03/07/2018 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

03/27/2017 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

03/27/2017 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

12/21/2014 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

12/21/2014 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

02/16/2012 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

12/08/2010 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 077406 CHARTWELL MOLECULES
ONDANSETRON ONDANSETRON 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078152 GLENMARK PHARMS LTD
ONDANSETRON ONDANSETRON 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 209389 IPCA LABS LTD
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

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 PHARMS LTD
ONDANSETRON ONDANSETRON 8MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 209389 IPCA LABS LTD
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
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