Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020741
Company: GEMINI LABS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRANDIN REPAGLINIDE 0.5MG TABLET;ORAL Prescription AB Yes No
PRANDIN REPAGLINIDE 1MG TABLET;ORAL Prescription AB Yes No
PRANDIN REPAGLINIDE 2MG TABLET;ORAL Prescription AB Yes 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
12/22/1997 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/1997/020741s044lbl.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/22/2019 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020741s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020741Orig1s044ltr.pdf
10/30/2015 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

02/08/2017 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020741s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020741Orig1s041,s042ltr.pdf
02/08/2017 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020741s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020741Orig1s041,s042ltr.pdf
03/01/2012 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020741s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020741s040ltr.pdf
07/29/2010 SUPPL-38 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020741s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020741s038ltr.pdf
06/10/2009 SUPPL-35 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020741s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020741s035ltr.pdf
07/14/2008 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020741s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020741s034ltr.pdf
06/19/2006 SUPPL-30 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020741s030LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020741_S030_PRANDIN_TABS_AP.pdf
02/10/2005 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20741s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20741s022ltr.pdf
10/15/2003 SUPPL-19 Manufacturing (CMC)-Packaging Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20741scp019ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020741_S019_PRANDIN_TABS_AP.pdf
08/27/2003 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20741slr018_prandin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20741slr018ltr.pdf
11/25/2002 SUPPL-16 Manufacturing (CMC)-Expiration Date Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020741_S016_PRANDIN_TABS_AP.pdf
10/01/2002 SUPPL-15 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020741_S015_PRANDIN_TABS_AP.pdf
08/05/2002 SUPPL-14 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/21/2002 SUPPL-13 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20741s13lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20741se1-013ltr.pdf
01/18/2002 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20741s12lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20741s12ltr.pdf
10/27/2000 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

08/15/2000 SUPPL-9 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020741_S009_PRANDIN_TABS_AP.pdf
02/25/2000 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/26/1999 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

12/08/1999 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/30/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/18/1999 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

05/18/1999 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/1999 SUPPL-2 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/10/1999 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/22/2019 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020741s044lbl.pdf
02/08/2017 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020741s041s042lbl.pdf
02/08/2017 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020741s041s042lbl.pdf
03/01/2012 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020741s040lbl.pdf
07/29/2010 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020741s038lbl.pdf
06/10/2009 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020741s035lbl.pdf
07/14/2008 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020741s034lbl.pdf
02/10/2005 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20741s022lbl.pdf
08/27/2003 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20741slr018_prandin_lbl.pdf
10/21/2002 SUPPL-13 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20741s13lbl.pdf
01/18/2002 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20741s12lbl.pdf
12/22/1997 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1997/020741s044lbl.pdf

PRANDIN

TABLET;ORAL; 0.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PRANDIN REPAGLINIDE 0.5MG TABLET;ORAL Prescription Yes AB 020741 GEMINI LABS LLC
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 090252 MYLAN 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
PRANDIN REPAGLINIDE 1MG TABLET;ORAL Prescription Yes AB 020741 GEMINI LABS LLC
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
PRANDIN REPAGLINIDE 2MG TABLET;ORAL Prescription Yes AB 020741 GEMINI LABS LLC
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

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