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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078139
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ONDANSETRON ONDANSETRON 4MG TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None No No
ONDANSETRON ONDANSETRON 8MG TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None 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
06/25/2007 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
01/31/2023 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

01/31/2023 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

03/07/2018 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

03/31/2017 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

12/07/2015 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

08/27/2013 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

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