Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202845
Company: HERITAGE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIFLUNISAL DIFLUNISAL 500MG TABLET;ORAL Prescription AB 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
03/08/2012 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-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

DIFLUNISAL

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIFLUNISAL DIFLUNISAL 500MG TABLET;ORAL Prescription No AB 202845 HERITAGE PHARMA
DIFLUNISAL DIFLUNISAL 500MG TABLET;ORAL Prescription No AB 073673 TEVA
DIFLUNISAL DIFLUNISAL 500MG TABLET;ORAL Prescription No AB 203547 ZYDUS PHARMS

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