NDA 007936

CHATTEM

FDA Drug Application

Application #007936

Application Sponsors

NDA 007936

CHATTEM

Marketing Status

• Discontinued: 001

Application Products

001

LOTION/SHAMPOO;TOPICAL

2.5%

1

SELSUN

SELENIUM SULFIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1951-05-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1976-07-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1976-11-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1977-03-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1977-03-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1977-09-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1979-01-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1979-01-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1981-01-09	STANDARD
LABELING; Labeling	SUPPL	14	AP	1983-01-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1982-09-15	STANDARD
LABELING; Labeling	SUPPL	16	AP	1983-09-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1988-05-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1993-01-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1994-06-24	STANDARD

Submissions Property Types

SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0

CDER Filings

CHATTEM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 7936
            [companyName] => CHATTEM
            [docInserts] => ["",""]
            [products] => [{"drugName":"SELSUN","activeIngredients":"SELENIUM SULFIDE","strength":"2.5%","dosageForm":"LOTION\/SHAMPOO;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SELSUN","submission":"SELENIUM SULFIDE","actionType":"2.5%","submissionClassification":"LOTION\/SHAMPOO;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)