NDA 020860

BAYER HLTHCARE

FDA Drug Application

Application #020860

Documents

• Letter: 1998-07-14
• Review: 1999-01-21

Application Sponsors

NDA 020860

BAYER HLTHCARE

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL-21	0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	LEVLITE	ETHINYL ESTRADIOL; LEVONORGESTREL
002	TABLET;ORAL-28	0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	LEVLITE	ETHINYL ESTRADIOL; LEVONORGESTREL

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1998-07-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2001-12-17	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20860
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)