Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074841
Company: CHARTWELL MOLECULES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ETODOLAC ETODOLAC 400MG 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
06/27/1997 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
05/09/2016 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/15/2002 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

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