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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077571
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 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 201189 PADAGIS US
REPAGLINIDE REPAGLINIDE 2MG TABLET;ORAL Prescription No AB 077571 SUN PHARM INDS INC
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