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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091220
Company: MICRO LABS

Products on ANDA 091220

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	3MG	TABLET;ORAL	Prescription	None	No	No
GLIMEPIRIDE	GLIMEPIRIDE	4MG	TABLET;ORAL	Prescription	AB	No	No
GLIMEPIRIDE	GLIMEPIRIDE	6MG	TABLET;ORAL	Prescription	None	No	No
GLIMEPIRIDE	GLIMEPIRIDE	8MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091220

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/29/2012	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
09/15/2020	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
04/07/2020	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
08/25/2017	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
12/03/2014	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
12/03/2014	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091220

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

TABLET;ORAL; 8MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GLIMEPIRIDE	GLIMEPIRIDE	8MG	TABLET;ORAL	Prescription	No	AB	091220	MICRO LABS
GLIMEPIRIDE	GLIMEPIRIDE	8MG	TABLET;ORAL	Prescription	No	AB	077370	PRINSTON INC

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