NDA 020045

BAYER HEALTHCARE LLC

FDA Drug Application

Application #020045

Application Sponsors

NDA 020045

BAYER HEALTHCARE LLC

Marketing Status

• Discontinued: 001

Application Products

001

LOTION;TOPICAL

3%;7.5%;3%

1

SHADE UVAGUARD

AVOBENZONE; OCTINOXATE; OXYBENZONE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1992-12-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1993-06-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1993-12-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1996-08-22	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0

CDER Filings

BAYER HEALTHCARE LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20045
            [companyName] => BAYER HEALTHCARE LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SHADE UVAGUARD","activeIngredients":"AVOBENZONE; OCTINOXATE; OXYBENZONE","strength":"3%;7.5%;3%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SHADE UVAGUARD","submission":"AVOBENZONE; OCTINOXATE; OXYBENZONE","actionType":"3%;7.5%;3%","submissionClassification":"LOTION;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)