Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078555
Company: CHARTWELL RX
Company: CHARTWELL RX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
REPAGLINIDE | REPAGLINIDE | 0.5MG | TABLET;ORAL | Prescription | AB | No | No |
REPAGLINIDE | REPAGLINIDE | 1MG | TABLET;ORAL | Prescription | AB | No | No |
REPAGLINIDE | REPAGLINIDE | 2MG | 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 |
---|---|---|---|---|---|---|---|
01/22/2014 | ORIG-2 | Approval |
Label is not available on this site. |
||||
11/22/2013 | ORIG-1 | Approval |
Label is not available on this site. |
REPAGLINIDE
TABLET;ORAL; 0.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
REPAGLINIDE | REPAGLINIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 203820 | AUROBINDO PHARMA LTD |
REPAGLINIDE | REPAGLINIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 078555 | CHARTWELL RX |
REPAGLINIDE | REPAGLINIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 207209 | MACLEODS PHARMS LTD |
REPAGLINIDE | REPAGLINIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 201189 | PADAGIS US |
TABLET;ORAL; 1MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
REPAGLINIDE | REPAGLINIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 203820 | AUROBINDO PHARMA LTD |
REPAGLINIDE | REPAGLINIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 078555 | CHARTWELL RX |
REPAGLINIDE | REPAGLINIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 207209 | MACLEODS PHARMS LTD |
REPAGLINIDE | REPAGLINIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 201189 | PADAGIS US |
REPAGLINIDE | REPAGLINIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 077571 | SUN PHARM INDS INC |
TABLET;ORAL; 2MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
REPAGLINIDE | REPAGLINIDE | 2MG | TABLET;ORAL | Prescription | No | AB | 203820 | AUROBINDO PHARMA LTD |
REPAGLINIDE | REPAGLINIDE | 2MG | TABLET;ORAL | Prescription | No | AB | 078555 | CHARTWELL RX |
REPAGLINIDE | REPAGLINIDE | 2MG | TABLET;ORAL | Prescription | No | AB | 207209 | MACLEODS PHARMS LTD |
REPAGLINIDE | REPAGLINIDE | 2MG | TABLET;ORAL | Prescription | No | AB | 201189 | PADAGIS US |
REPAGLINIDE | REPAGLINIDE | 2MG | TABLET;ORAL | Prescription | No | AB | 077571 | SUN PHARM INDS INC |