Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078181
Company: ACCORD HLTHCARE
Company: ACCORD HLTHCARE
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 |
---|---|---|---|---|---|---|---|
08/23/2007 | 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 |
---|---|---|---|---|---|
05/31/2019 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
08/25/2017 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
11/03/2014 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
08/01/2014 | SUPPL-6 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
06/01/2012 | SUPPL-5 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
12/30/2009 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
12/30/2009 | SUPPL-2 | 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 |