Drugs@FDA: FDA-Approved Drugs
Company: DR REDDYS LABS LTD
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/2005/077091ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/31/2019 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
05/31/2019 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
04/24/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
04/24/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
04/24/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
11/30/2009 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
11/30/2009 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
11/13/2007 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
08/15/2006 | 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 | 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 |