Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020496
Company: SANOFI AVENTIS US
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 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020496Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/21/2018 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020496s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020496Orig1s029Ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 12/21/2018 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020496s029lbl.pdf | |
| 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 | 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 |