Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074285
Company: PUREPAC PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIFLUNISAL DIFLUNISAL 250MG TABLET;ORAL Discontinued None No No
DIFLUNISAL DIFLUNISAL 500MG 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
05/07/1996 ORIG-1 Approval Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/96/074285_diflunisal_toc.cfm

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