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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077295
Company: CHARTWELL MOLECULAR

Products on ANDA 077295

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 077295

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/06/2005	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077295ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/24/2015	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
04/24/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
10/25/2010	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
06/23/2010	SUPPL-3	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
06/11/2009	SUPPL-2	Labeling		Label is not available on this site.
12/26/2007	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077295

GLIMEPIRIDE

TABLET;ORAL; 1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMARYL	GLIMEPIRIDE	1MG	TABLET;ORAL	Prescription	Yes	AB	020496	SANOFI AVENTIS US
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	202112	INDOCO REMEDIES
GLIMEPIRIDE	GLIMEPIRIDE	1MG	TABLET;ORAL	Prescription	No	AB	091220	MICRO LABS
GLIMEPIRIDE	GLIMEPIRIDE	1MG	TABLET;ORAL	Prescription	No	AB	077370	PRINSTON INC

TABLET;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMARYL	GLIMEPIRIDE	2MG	TABLET;ORAL	Prescription	Yes	AB	020496	SANOFI AVENTIS US
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	202112	INDOCO REMEDIES
GLIMEPIRIDE	GLIMEPIRIDE	2MG	TABLET;ORAL	Prescription	No	AB	091220	MICRO LABS
GLIMEPIRIDE	GLIMEPIRIDE	2MG	TABLET;ORAL	Prescription	No	AB	077370	PRINSTON INC

TABLET;ORAL; 4MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMARYL	GLIMEPIRIDE	4MG	TABLET;ORAL	Prescription	Yes	AB	020496	SANOFI AVENTIS US
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	202112	INDOCO REMEDIES
GLIMEPIRIDE	GLIMEPIRIDE	4MG	TABLET;ORAL	Prescription	No	AB	091220	MICRO LABS
GLIMEPIRIDE	GLIMEPIRIDE	4MG	TABLET;ORAL	Prescription	No	AB	077370	PRINSTON INC

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