Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090252
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
REPAGLINIDE REPAGLINIDE 0.5MG TABLET;ORAL Discontinued 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
01/22/2014 ORIG-2 Approval

Label is not available on this site.

08/23/2013 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
07/07/2015 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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 090008 ACTAVIS TOTOWA
REPAGLINIDE REPAGLINIDE 1MG TABLET;ORAL Prescription No AB 203820 AUROBINDO PHARMA LTD
REPAGLINIDE REPAGLINIDE 1MG TABLET;ORAL Prescription No AB 091517 BOSCOGEN
REPAGLINIDE REPAGLINIDE 1MG TABLET;ORAL Prescription No AB 078555 CASI PHARMS INC
REPAGLINIDE REPAGLINIDE 1MG TABLET;ORAL Prescription No AB 090252 MYLAN
REPAGLINIDE REPAGLINIDE 1MG TABLET;ORAL Prescription No AB 201189 PADDOCK LLC
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 090008 ACTAVIS TOTOWA
REPAGLINIDE REPAGLINIDE 2MG TABLET;ORAL Prescription No AB 203820 AUROBINDO PHARMA LTD
REPAGLINIDE REPAGLINIDE 2MG TABLET;ORAL Prescription No AB 091517 BOSCOGEN
REPAGLINIDE REPAGLINIDE 2MG TABLET;ORAL Prescription No AB 078555 CASI PHARMS INC
REPAGLINIDE REPAGLINIDE 2MG TABLET;ORAL Prescription No AB 090252 MYLAN
REPAGLINIDE REPAGLINIDE 2MG TABLET;ORAL Prescription No AB 201189 PADDOCK LLC
REPAGLINIDE REPAGLINIDE 2MG TABLET;ORAL Prescription No AB 077571 SUN PHARM INDS INC

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