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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 077571

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	Prescription	AB	No	No
REPAGLINIDE	REPAGLINIDE	2MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077571

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/11/2013	ORIG-1	Approval			Label (PDF) Letter (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/077571s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077571taltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/077571Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/01/2019	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
10/01/2019	SUPPL-8	Labeling-Package Insert		Label is not available on this site.

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

Therapeutic Equivalents for ANDA 077571

REPAGLINIDE

TABLET;ORAL; 1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
REPAGLINIDE	REPAGLINIDE	1MG	TABLET;ORAL	Prescription	No	AB	203820	AUROBINDO PHARMA LTD
REPAGLINIDE	REPAGLINIDE	1MG	TABLET;ORAL	Prescription	No	AB	078555	CHARTWELL RX
REPAGLINIDE	REPAGLINIDE	1MG	TABLET;ORAL	Prescription	No	AB	207209	MACLEODS PHARMS LTD
REPAGLINIDE	REPAGLINIDE	1MG	TABLET;ORAL	Prescription	No	AB	201189	PADAGIS US
REPAGLINIDE	REPAGLINIDE	1MG	TABLET;ORAL	Prescription	No	AB	077571	SUN PHARM INDS INC

TABLET;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
REPAGLINIDE	REPAGLINIDE	2MG	TABLET;ORAL	Prescription	No	AB	203820	AUROBINDO PHARMA LTD
REPAGLINIDE	REPAGLINIDE	2MG	TABLET;ORAL	Prescription	No	AB	078555	CHARTWELL RX
REPAGLINIDE	REPAGLINIDE	2MG	TABLET;ORAL	Prescription	No	AB	207209	MACLEODS PHARMS LTD
REPAGLINIDE	REPAGLINIDE	2MG	TABLET;ORAL	Prescription	No	AB	201189	PADAGIS US
REPAGLINIDE	REPAGLINIDE	2MG	TABLET;ORAL	Prescription	No	AB	077571	SUN PHARM INDS INC

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