Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077303
Company: CHARTWELL MOLECULES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Discontinued None No No
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET;ORAL Discontinued None No No
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE 16MG TABLET; ORAL None (Tentative Approval) None No No
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET;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
02/26/2018 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

10/23/2015 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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