Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078181
Company: ACCORD HLTHCARE
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
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
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-Container/Carton Labels, Labeling-Package Insert

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.

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 077091 DR REDDYS LABS LTD
GLIMEPIRIDE GLIMEPIRIDE 1MG TABLET;ORAL Prescription No AB 202112 INDOCO REMEDIES
GLIMEPIRIDE GLIMEPIRIDE 1MG TABLET;ORAL Prescription No AB 077295 INVAGEN PHARMS
GLIMEPIRIDE GLIMEPIRIDE 1MG TABLET;ORAL Prescription No AB 091220 MICRO LABS
GLIMEPIRIDE GLIMEPIRIDE 1MG TABLET;ORAL Prescription No AB 077624 MYLAN
GLIMEPIRIDE GLIMEPIRIDE 1MG TABLET;ORAL Prescription No AB 077370 PRINSTON INC
GLIMEPIRIDE GLIMEPIRIDE 1MG TABLET;ORAL Prescription No AB 076802 TEVA

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 077091 DR REDDYS LABS LTD
GLIMEPIRIDE GLIMEPIRIDE 2MG TABLET;ORAL Prescription No AB 202112 INDOCO REMEDIES
GLIMEPIRIDE GLIMEPIRIDE 2MG TABLET;ORAL Prescription No AB 077295 INVAGEN PHARMS
GLIMEPIRIDE GLIMEPIRIDE 2MG TABLET;ORAL Prescription No AB 091220 MICRO LABS
GLIMEPIRIDE GLIMEPIRIDE 2MG TABLET;ORAL Prescription No AB 077624 MYLAN
GLIMEPIRIDE GLIMEPIRIDE 2MG TABLET;ORAL Prescription No AB 077370 PRINSTON INC
GLIMEPIRIDE GLIMEPIRIDE 2MG TABLET;ORAL Prescription No AB 076802 TEVA

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 077091 DR REDDYS LABS LTD
GLIMEPIRIDE GLIMEPIRIDE 4MG TABLET;ORAL Prescription No AB 202112 INDOCO REMEDIES
GLIMEPIRIDE GLIMEPIRIDE 4MG TABLET;ORAL Prescription No AB 077295 INVAGEN PHARMS
GLIMEPIRIDE GLIMEPIRIDE 4MG TABLET;ORAL Prescription No AB 091220 MICRO LABS
GLIMEPIRIDE GLIMEPIRIDE 4MG TABLET;ORAL Prescription No AB 077624 MYLAN
GLIMEPIRIDE GLIMEPIRIDE 4MG TABLET;ORAL Prescription No AB 077370 PRINSTON INC
GLIMEPIRIDE GLIMEPIRIDE 4MG TABLET;ORAL Prescription No AB 076802 TEVA

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