NDA 013718

GEMINI LABS LLC

FDA Drug Application

Application #013718

Documents

• Letter: 2001-11-05
• Letter: 2005-06-21
• Label: 2003-06-10
• Label: 2005-06-21
• Letter: 2001-11-05
• Letter: 2003-05-29
• Label: 2003-06-10
• Label: 2003-05-28
• Review: 2006-10-25

Application Sponsors

NDA 013718

GEMINI LABS LLC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	2.5MG	1	OXANDRIN	OXANDROLONE
002	TABLET;ORAL	10MG	1	OXANDRIN	OXANDROLONE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1964-07-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1979-11-30	STANDARD
LABELING; Labeling	SUPPL	12	AP	1987-02-24
LABELING; Labeling	SUPPL	13	AP	1991-10-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1997-07-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1999-10-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1999-08-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2001-11-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2001-11-05	STANDARD
LABELING; Labeling	SUPPL	22	AP	2003-04-21	STANDARD
EFFICACY; Efficacy	SUPPL	23	AP	2005-06-20	UNKNOWN

Submissions Property Types

SUPPL	7	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 13718
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)