Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077571
Company: SUN PHARM INDS INC
Company: SUN PHARM INDS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
REPAGLINIDE | REPAGLINIDE | 0.5MG | TABLET; ORAL | None (Tentative Approval) | None | 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 |
---|---|---|---|---|---|---|---|
07/11/2013 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/077571s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077571taltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/077571Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/01/2019 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
10/01/2019 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/11/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/077571s000lbl.pdf |
REPAGLINIDE
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 |