NDA 018297

ABBOTT

FDA Drug Application

Application #018297

Application Sponsors

NDA 018297

ABBOTT

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	100MG	0	LOPURIN	ALLOPURINOL
002	TABLET;ORAL	300MG	0	LOPURIN	ALLOPURINOL

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1980-06-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1982-01-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1982-01-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1981-06-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1985-02-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1981-03-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1986-01-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1985-03-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1985-11-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1985-05-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1986-03-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1986-07-21	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	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0

CDER Filings

ABBOTT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18297
            [companyName] => ABBOTT
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOPURIN","activeIngredients":"ALLOPURINOL","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LOPURIN","activeIngredients":"ALLOPURINOL","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LOPURIN","submission":"ALLOPURINOL","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LOPURIN","submission":"ALLOPURINOL","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)