Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077295
Company: INVAGEN PHARMS
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
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-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

06/23/2010 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Package Insert

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.

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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