Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203547
Company: ZYDUS PHARMS

Products on ANDA 203547

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 203547

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/16/2017	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203547Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2021	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203547

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