Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077624
Company: MYLAN
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
11/28/2005 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
04/17/2017 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

04/26/2016 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

05/19/2009 SUPPL-3 Labeling

Label is not available on this site.

10/01/2007 SUPPL-1 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 077624 MYLAN
GLIMEPIRIDE GLIMEPIRIDE 1MG TABLET;ORAL Prescription No AB 077370 PRINSTON INC
GLIMEPIRIDE GLIMEPIRIDE 1MG TABLET;ORAL Prescription No AB 076802 TEVA
GLIMEPIRIDE GLIMEPIRIDE 1MG TABLET;ORAL Prescription No AB 091220 VIVA HLTHCARE

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 077624 MYLAN
GLIMEPIRIDE GLIMEPIRIDE 2MG TABLET;ORAL Prescription No AB 077370 PRINSTON INC
GLIMEPIRIDE GLIMEPIRIDE 2MG TABLET;ORAL Prescription No AB 076802 TEVA
GLIMEPIRIDE GLIMEPIRIDE 2MG TABLET;ORAL Prescription No AB 091220 VIVA HLTHCARE

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 077624 MYLAN
GLIMEPIRIDE GLIMEPIRIDE 4MG TABLET;ORAL Prescription No AB 077370 PRINSTON INC
GLIMEPIRIDE GLIMEPIRIDE 4MG TABLET;ORAL Prescription No AB 076802 TEVA
GLIMEPIRIDE GLIMEPIRIDE 4MG TABLET;ORAL Prescription No AB 091220 VIVA HLTHCARE

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