Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201189
Company: PADAGIS US
Company: PADAGIS US
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 | Not Applicable |
Label is not available on this site. |
|||
07/17/2013 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/28/2019 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
10/28/2019 | SUPPL-5 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
08/26/2013 | SUPPL-1 | Labeling-Package Insert |
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 |