Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 203820
Company: AUROBINDO PHARMA LTD
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 Yes
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-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 090008 ACTAVIS TOTOWA
REPAGLINIDE REPAGLINIDE 0.5MG TABLET;ORAL Prescription No AB 203820 AUROBINDO PHARMA LTD
REPAGLINIDE REPAGLINIDE 0.5MG TABLET;ORAL Prescription No AB 091517 BOSCOGEN
REPAGLINIDE REPAGLINIDE 0.5MG TABLET;ORAL Prescription No AB 078555 CASI PHARMS INC
REPAGLINIDE REPAGLINIDE 0.5MG TABLET;ORAL Prescription No AB 201189 PADDOCK LLC

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 PHARMS INC
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 PHARMS INC
REPAGLINIDE REPAGLINIDE 2MG TABLET;ORAL Prescription No AB 201189 PADDOCK LLC
REPAGLINIDE REPAGLINIDE 2MG TABLET;ORAL Prescription No AB 077571 SUN PHARM INDS INC

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English