An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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.

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
REPAGLINIDE	REPAGLINIDE	0.5MG	TABLET;ORAL	Prescription	No	AB	201189	PADAGIS US

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

Top