NDA 018104

PHARMACIA AND UPJOHN

FDA Drug Application

Application #018104

Application Sponsors

NDA 018104

PHARMACIA AND UPJOHN

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	10MG	0	HYLOREL	GUANADREL SULFATE
002	TABLET;ORAL	25MG	0	HYLOREL	GUANADREL SULFATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1982-12-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1983-09-13	STANDARD
LABELING; Labeling	SUPPL	3	AP	1985-08-20
LABELING; Labeling	SUPPL	4	AP	1985-08-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1986-10-07	STANDARD
LABELING; Labeling	SUPPL	6	AP	1990-08-01
LABELING; Labeling	SUPPL	7	AP	1990-08-01

Submissions Property Types

SUPPL	2	Null	0
SUPPL	5	Null	0

CDER Filings

PHARMACIA AND UPJOHN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18104
            [companyName] => PHARMACIA AND UPJOHN
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYLOREL","activeIngredients":"GUANADREL SULFATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HYLOREL","activeIngredients":"GUANADREL SULFATE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYLOREL","submission":"GUANADREL SULFATE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HYLOREL","submission":"GUANADREL SULFATE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)