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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078555
Company: CHARTWELL RX

Products on ANDA 078555

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
REPAGLINIDE	REPAGLINIDE	0.5MG	TABLET;ORAL	Prescription	AB	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 078555

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/22/2014	ORIG-2	Approval				Label is not available on this site.
11/22/2013	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
07/01/2025	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
07/01/2025	SUPPL-8	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078555

REPAGLINIDE

TABLET;ORAL; 0.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
REPAGLINIDE	REPAGLINIDE	0.5MG	TABLET;ORAL	Prescription	No	AB	203820	AUROBINDO PHARMA LTD
REPAGLINIDE	REPAGLINIDE	0.5MG	TABLET;ORAL	Prescription	No	AB	078555	CHARTWELL RX
REPAGLINIDE	REPAGLINIDE	0.5MG	TABLET;ORAL	Prescription	No	AB	207209	MACLEODS PHARMS LTD

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

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

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