01 3ACTAVIS TOTOWA
02 3AUROBINDO PHARMA LTD
03 3CHARTWELL RX
04 3GEMINI LABS LLC
05 3KENTON
06 2LUPIN LTD
07 3MACLEODS PHARMS LTD
08 3NORVIUM BIOSCIENCE
09 2NOVO NORDISK INC
10 3PADAGIS US
11 3SUN PHARM INDS INC
01 1TABLET; ORAL
02 30TABLET;ORAL
01 16DISCN
02 14RX
03 1Blank
01 2PRANDIMET
02 3PRANDIN
03 24REPAGLINIDE
04 2REPAGLINIDE AND METFORMIN HYDROCHLORIDE
01 25No
02 5Yes
03 1Blank
RLD : No
TE Code : AB
Brand Name : REPAGLINIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 0.5MG
Approval Date : 2013-11-22
Application Number : 78555
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : REPAGLINIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 1MG
Approval Date : 2014-01-22
Application Number : 78555
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : Yes
TE Code :
Brand Name : PRANDIN
Dosage Form : TABLET;ORAL
Dosage Strength : 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1997-12-22
Application Number : 20741
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : PRANDIN
Dosage Form : TABLET;ORAL
Dosage Strength : 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1997-12-22
Application Number : 20741
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : PRANDIN
Dosage Form : TABLET;ORAL
Dosage Strength : 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1997-12-22
Application Number : 20741
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
METFORMIN HYDROCHLORIDE; REPAGLINIDE
Brand Name : PRANDIMET
Dosage Form : TABLET;ORAL
Dosage Strength : 500MG;1MG
Approval Date : 2008-06-23
Application Number : 22386
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
METFORMIN HYDROCHLORIDE; REPAGLINIDE
Brand Name : PRANDIMET
Dosage Form : TABLET;ORAL
Dosage Strength : 500MG;2MG
Approval Date : 2008-06-23
Application Number : 22386
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD :
TE Code :
Brand Name : REPAGLINIDE
Dosage Form : TABLET; ORAL
Dosage Strength : 0.5MG
Approval Date :
Application Number : 77571
RX/OTC/DISCN :
RLD :
TE Code :
RLD : No
TE Code : AB
Brand Name : REPAGLINIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 1MG
Approval Date : 2013-07-11
Application Number : 77571
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : REPAGLINIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 2MG
Approval Date : 2013-07-11
Application Number : 77571
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
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