NDA 020741

GEMINI LABS LLC

FDA Drug Application

Application #020741

Documents

• Letter: 2002-01-18
• Letter: 2003-10-17
• Letter: 2005-02-11
• Letter: 2006-06-28
• Letter: 2008-07-15
• Letter: 2009-06-16
• Letter: 2010-08-03
• Letter: 2012-03-05
• Label: 2002-01-18
• Label: 2002-10-21
• Label: 2003-08-29
• Label: 2005-02-11
• Label: 2008-07-15
• Label: 2010-07-31
• Label: 2012-03-06
• Review: 2007-07-06
• Review: 2007-07-06
• Letter: 2002-10-21
• Letter: 2003-08-29
• Label: 2009-06-22
• Review: 2007-07-06
• Review: 2007-07-06
• Review: 2007-07-06
• Label: 2017-02-09
• Label: 2017-02-09
• Letter: 2017-02-09
• Letter: 2017-02-09
• Label: 2019-01-23
• Label: 2019-01-23
• Letter: 2019-02-13

Application Sponsors

NDA 020741

GEMINI LABS LLC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	0.5MG	1	PRANDIN	REPAGLINIDE
002	TABLET;ORAL	1MG	1	PRANDIN	REPAGLINIDE
003	TABLET;ORAL	2MG	1	PRANDIN	REPAGLINIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1997-12-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1999-03-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1999-05-18	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1999-05-18	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1999-08-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1999-12-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1999-11-26	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-02-25	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2000-08-15	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2000-10-27	PRIORITY
EFFICACY; Efficacy	SUPPL	12	AP	2002-01-18	STANDARD
EFFICACY; Efficacy	SUPPL	13	AP	2002-10-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2002-08-05	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2002-10-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2002-11-25	PRIORITY
LABELING; Labeling	SUPPL	18	AP	2003-08-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2003-10-15	PRIORITY
LABELING; Labeling	SUPPL	22	AP	2005-02-10	STANDARD
LABELING; Labeling	SUPPL	30	AP	2006-06-19	STANDARD
LABELING; Labeling	SUPPL	34	AP	2008-07-14	STANDARD
LABELING; Labeling	SUPPL	35	AP	2009-06-10	STANDARD
LABELING; Labeling	SUPPL	38	AP	2010-07-29	UNKNOWN
LABELING; Labeling	SUPPL	40	AP	2012-03-01	STANDARD
LABELING; Labeling	SUPPL	41	AP	2017-02-08	UNKNOWN
LABELING; Labeling	SUPPL	42	AP	2017-02-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	2015-10-30	PRIORITY
LABELING; Labeling	SUPPL	44	AP	2019-01-22	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	19	Null	0
SUPPL	38	Null	7
SUPPL	40	Null	7
SUPPL	41	Null	7
SUPPL	42	Null	31
SUPPL	43	Null	0
SUPPL	44	Null	15

CDER Filings

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(
    [0] => Array
        (
            [ApplNo] => 20741
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)