Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077571
Company: SUN PHARM INDS INC

• Package Label

Products on ANDA 77571

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
REPAGLINIDE	REPAGLINIDE	0.5MG	TABLET; ORAL	None (Tentative Approval)	None	No	No
REPAGLINIDE	REPAGLINIDE	1MG	TABLET;ORAL	Discontinued	None	No	No
REPAGLINIDE	REPAGLINIDE	2MG	TABLET;ORAL	Discontinued	None	No	No

Labels for ANDA 077571

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/11/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/077571s000lbl.pdf