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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077717
Company: NESHER PHARMS
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
05/23/2007 ORIG-1 Tentative Approval

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