NDA 021258

BAYER HLTHCARE

FDA Drug Application

Application #021258

Documents

• Letter: 2003-11-28
• Letter: 2005-06-24
• Letter: 2013-10-11
• Review: 2006-06-07
• Label: 2004-04-01
• Label: 2005-06-24
• Label: 2013-10-17
• Label: 2017-11-02
• Letter: 2021-10-12
• Letter: 2021-11-16
• Label: 2021-11-16

Application Sponsors

NDA 021258

BAYER HLTHCARE

Marketing Status

• Prescription: 001

Application Products

001

FILM, EXTENDED RELEASE;TRANSDERMAL

0.045MG/24HR;0.015MG/24HR

1

CLIMARA PRO

ESTRADIOL; LEVONORGESTREL

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2003-11-21	STANDARD
LABELING; Labeling	SUPPL	3	AP	2005-06-22	STANDARD
LABELING; Labeling	SUPPL	6	AP	2013-10-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2016-03-08	STANDARD
LABELING; Labeling	SUPPL	11	AP	2017-11-01	STANDARD
LABELING; Labeling	SUPPL	12	AP	2021-11-15	STANDARD
LABELING; Labeling	SUPPL	13	AP	2021-10-07	STANDARD

Submissions Property Types

SUPPL	6	Null	7
SUPPL	10	Null	0
SUPPL	11	Null	15
SUPPL	12	Null	6
SUPPL	13	Null	15

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21258
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)