NDA 018154

PHARMACIA AND UPJOHN

FDA Drug Application

Application #018154

Documents

• Letter: 2002-07-09
• Label: 2015-01-14
• Letter: 2015-01-15

Application Sponsors

NDA 018154

PHARMACIA AND UPJOHN

Marketing Status

• Discontinued: 001
• Discontinued: 003

Application Products

001	TABLET;ORAL	2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	LONITEN	MINOXIDIL
003	TABLET;ORAL	10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	LONITEN	MINOXIDIL

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1979-10-18	PRIORITY
LABELING; Labeling	SUPPL	2	AP	1982-04-12
LABELING; Labeling	SUPPL	3	AP	1982-12-07
LABELING; Labeling	SUPPL	4	AP	1982-02-08
LABELING; Labeling	SUPPL	5	AP	1983-06-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1984-02-07	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1984-11-28	PRIORITY
LABELING; Labeling	SUPPL	9	AP	1985-10-15
LABELING; Labeling	SUPPL	12	AP	1985-12-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1986-07-28	PRIORITY
LABELING; Labeling	SUPPL	15	AP	1986-12-22
LABELING; Labeling	SUPPL	16	AP	1987-10-20
LABELING; Labeling	SUPPL	17	AP	1992-05-19
LABELING; Labeling	SUPPL	18	AP	1993-02-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1994-04-08	PRIORITY
LABELING; Labeling	SUPPL	20	AP	1994-04-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1996-03-11	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2001-08-08	PRIORITY
LABELING; Labeling	SUPPL	23	AP	2002-07-09	STANDARD
LABELING; Labeling	SUPPL	26	AP	2015-01-13	STANDARD

Submissions Property Types

SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	14	Null	0
SUPPL	19	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	26	Null	15

CDER Filings

PFIZER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18154
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"LONITEN","activeIngredients":"MINOXIDIL","strength":"2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"LONITEN","activeIngredients":"MINOXIDIL","strength":"10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"01\/13\/2015","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/018154s026lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LONITEN","submission":"MINOXIDIL","actionType":"2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"LONITEN","submission":"MINOXIDIL","actionType":"10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2015-01-13
        )

)