Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202845
Company: HERITAGE PHARMA

Products on ANDA 202845

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIFLUNISAL	DIFLUNISAL	500MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202845

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
04/28/2021	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/09/2016	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202845

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