NDA 021137

GENUS LIFESCIENCES

FDA Drug Application

Application #021137

Documents

• Label: 2004-06-08
• Letter: 2003-06-08
• Review: 2004-06-04
• Label: 2021-12-19
• Label: 2021-12-19
• Label: 2021-12-19
• Letter: 2021-12-21
• Letter: 2021-12-21
• Letter: 2021-12-21
• Letter: 2022-08-08

Application Sponsors

NDA 021137

GENUS LIFESCIENCES

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005
• Discontinued: 006
• Discontinued: 007
• Discontinued: 008
• Discontinued: 009
• Discontinued: 010
• Discontinued: 011
• Discontinued: 012

Application Products

001	TABLET;ORAL	0.025MG	0	LEVOLET	LEVOTHYROXINE SODIUM
002	TABLET;ORAL	0.05MG	0	LEVOLET	LEVOTHYROXINE SODIUM
003	TABLET;ORAL	0.075MG	0	LEVOLET	LEVOTHYROXINE SODIUM
004	TABLET;ORAL	0.088MG	0	LEVOLET	LEVOTHYROXINE SODIUM
005	TABLET;ORAL	0.1MG	0	LEVOLET	LEVOTHYROXINE SODIUM
006	TABLET;ORAL	0.112MG	0	LEVOLET	LEVOTHYROXINE SODIUM
007	TABLET;ORAL	0.125MG	0	LEVOLET	LEVOTHYROXINE SODIUM
008	TABLET;ORAL	0.137MG	0	LEVOLET	LEVOTHYROXINE SODIUM
009	TABLET;ORAL	0.15MG	0	LEVOLET	LEVOTHYROXINE SODIUM
010	TABLET;ORAL	0.175MG	0	LEVOLET	LEVOTHYROXINE SODIUM
011	TABLET;ORAL	0.2MG	0	LEVOLET	LEVOTHYROXINE SODIUM
012	TABLET;ORAL	0.3MG	0	LEVOLET	LEVOTHYROXINE SODIUM

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2003-06-06	STANDARD
EFFICACY; Efficacy	SUPPL	2	AP	2021-12-17	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2021-12-17	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	2021-12-17	STANDARD
EFFICACY; Efficacy	SUPPL	5	AP	2022-08-05	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	2	Null	6
SUPPL	3	Null	6
SUPPL	4	Null	6
SUPPL	5	Null	7

TE Codes

001	Prescription	AB1
002	Prescription	AB1
003	Prescription	AB1
004	Prescription	AB1
005	Prescription	AB1
006	Prescription	AB1
007	Prescription	AB1
008	Prescription	AB1
009	Prescription	AB1
010	Prescription	AB1
011	Prescription	AB1
012	Prescription	AB1

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21137
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)