Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020496
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMARYL GLIMEPIRIDE 1MG TABLET;ORAL Prescription AB Yes Yes
AMARYL GLIMEPIRIDE 2MG TABLET;ORAL Prescription AB Yes No
AMARYL GLIMEPIRIDE 4MG TABLET;ORAL Prescription AB Yes 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
11/30/1995 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/19/2016 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020496s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020496Orig1s028ltr.pdf
10/15/2013 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020496s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020496Orig1s027ltr.pdf
08/01/2013 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020496s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020496Orig1s026ltr.pdf
04/19/2013 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

03/14/2013 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/03/2012 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020496s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020496s022ltr.pdf
06/04/2009 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020496s021ltr.pdf
02/03/2009 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s018s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020496s018, s019ltr.pdf
02/03/2009 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s018s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020496s018, s019ltr.pdf
09/19/2005 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020496s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020496s016ltr.pdf
11/28/2005 SUPPL-15 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020496s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020496s015ltr.pdf
08/16/2004 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20496s013ltr.pdf
07/21/2001 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/05/2000 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/2000 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

04/15/2002 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20496s7ltr.pdf
01/06/2000 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/27/2000 SUPPL-5 Efficacy-Labeling Change With Clinical Data Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20496-S005_Amaryl.pdf
09/16/1998 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/16/1998 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/24/1999 SUPPL-2 Efficacy-New Indication Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20496s2ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020496S002.cfm
07/28/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/19/2016 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020496s028lbl.pdf
10/15/2013 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020496s027lbl.pdf
08/01/2013 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020496s026lbl.pdf
02/03/2012 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020496s022lbl.pdf
06/04/2009 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s021lbl.pdf
02/03/2009 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s018s019lbl.pdf
02/03/2009 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s018s019lbl.pdf
11/28/2005 SUPPL-15 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020496s015lbl.pdf
09/19/2005 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020496s016lbl.pdf

AMARYL

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 LTD INDIA
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 LTD INDIA
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 LTD INDIA
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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