Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078181
Company: ACCORD HLTHCARE

Products on ANDA 078181

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GLIMEPIRIDE	GLIMEPIRIDE	1MG	TABLET;ORAL	Prescription	AB	No	No
GLIMEPIRIDE	GLIMEPIRIDE	2MG	TABLET;ORAL	Prescription	AB	No	No
GLIMEPIRIDE	GLIMEPIRIDE	4MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078181

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/23/2007	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
05/31/2019	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
08/25/2017	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
11/03/2014	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
08/01/2014	SUPPL-6	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
06/01/2012	SUPPL-5	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
12/30/2009	SUPPL-3	Labeling		Label is not available on this site.
12/30/2009	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 078181

GLIMEPIRIDE

TABLET;ORAL; 1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GLIMEPIRIDE	GLIMEPIRIDE	1MG	TABLET;ORAL	Prescription	No	AB	078181	ACCORD HLTHCARE
GLIMEPIRIDE	GLIMEPIRIDE	1MG	TABLET;ORAL	Prescription	No	AB	202759	AUROBINDO PHARMA LTD
GLIMEPIRIDE	GLIMEPIRIDE	1MG	TABLET;ORAL	Prescription	No	AB	077911	CARLSBAD
GLIMEPIRIDE	GLIMEPIRIDE	1MG	TABLET;ORAL	Prescription	No	AB	077295	CHARTWELL MOLECULAR
GLIMEPIRIDE	GLIMEPIRIDE	1MG	TABLET;ORAL	Prescription	No	AB	077091	DR REDDYS LABS LTD
GLIMEPIRIDE	GLIMEPIRIDE	1MG	TABLET;ORAL	Prescription	No	AB	091220	MICRO LABS
GLIMEPIRIDE	GLIMEPIRIDE	1MG	TABLET;ORAL	Prescription	No	AB	077370	PRINSTON INC
GLIMEPIRIDE	GLIMEPIRIDE	1MG	TABLET;ORAL	Prescription	No	AB	202112	REGCON HOLDINGS

TABLET;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GLIMEPIRIDE	GLIMEPIRIDE	2MG	TABLET;ORAL	Prescription	No	AB	078181	ACCORD HLTHCARE
GLIMEPIRIDE	GLIMEPIRIDE	2MG	TABLET;ORAL	Prescription	No	AB	202759	AUROBINDO PHARMA LTD
GLIMEPIRIDE	GLIMEPIRIDE	2MG	TABLET;ORAL	Prescription	No	AB	077911	CARLSBAD
GLIMEPIRIDE	GLIMEPIRIDE	2MG	TABLET;ORAL	Prescription	No	AB	077295	CHARTWELL MOLECULAR
GLIMEPIRIDE	GLIMEPIRIDE	2MG	TABLET;ORAL	Prescription	No	AB	077091	DR REDDYS LABS LTD
GLIMEPIRIDE	GLIMEPIRIDE	2MG	TABLET;ORAL	Prescription	No	AB	091220	MICRO LABS
GLIMEPIRIDE	GLIMEPIRIDE	2MG	TABLET;ORAL	Prescription	No	AB	077370	PRINSTON INC
GLIMEPIRIDE	GLIMEPIRIDE	2MG	TABLET;ORAL	Prescription	No	AB	202112	REGCON HOLDINGS

TABLET;ORAL; 4MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GLIMEPIRIDE	GLIMEPIRIDE	4MG	TABLET;ORAL	Prescription	No	AB	078181	ACCORD HLTHCARE
GLIMEPIRIDE	GLIMEPIRIDE	4MG	TABLET;ORAL	Prescription	No	AB	202759	AUROBINDO PHARMA LTD
GLIMEPIRIDE	GLIMEPIRIDE	4MG	TABLET;ORAL	Prescription	No	AB	077911	CARLSBAD
GLIMEPIRIDE	GLIMEPIRIDE	4MG	TABLET;ORAL	Prescription	No	AB	077295	CHARTWELL MOLECULAR
GLIMEPIRIDE	GLIMEPIRIDE	4MG	TABLET;ORAL	Prescription	No	AB	077091	DR REDDYS LABS LTD
GLIMEPIRIDE	GLIMEPIRIDE	4MG	TABLET;ORAL	Prescription	No	AB	091220	MICRO LABS
GLIMEPIRIDE	GLIMEPIRIDE	4MG	TABLET;ORAL	Prescription	No	AB	077370	PRINSTON INC
GLIMEPIRIDE	GLIMEPIRIDE	4MG	TABLET;ORAL	Prescription	No	AB	202112	REGCON HOLDINGS