Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077406
Company: CHARTWELL MOLECULES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ONDANSETRON ONDANSETRON 16MG TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None No No
ONDANSETRON ONDANSETRON 24MG TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None No No
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
12/26/2006 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077406s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/26/2018 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

09/28/2015 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

01/04/2008 SUPPL-4 Labeling

Label is not available on this site.

10/31/2007 SUPPL-3 Labeling

Label is not available on this site.

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