NDA 016000

BAYER HLTHCARE

FDA Drug Application

Application #016000

Application Sponsors

NDA 016000

BAYER HLTHCARE

Marketing Status

• Discontinued: 002

Application Products

002

TABLET;ORAL

500MG

0

SULLA

SULFAMETER

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1966-07-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1975-05-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1976-04-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1976-11-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1977-08-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1977-08-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1978-01-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1979-02-13	STANDARD
LABELING; Labeling	SUPPL	10	AP	1979-01-10	STANDARD
LABELING; Labeling	SUPPL	12	AP	1980-01-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1980-06-27	STANDARD
LABELING; Labeling	SUPPL	14	AP	1980-06-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1981-01-16	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16000
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)