NDA 050448

JOHNSON AND JOHNSON

FDA Drug Application

Application #050448

Application Sponsors

NDA 050448

JOHNSON AND JOHNSON

Marketing Status

• Discontinued: 001

Application Products

001

SUSPENSION;ORAL

125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

GRIFULVIN V

GRISEOFULVIN, MICROCRYSTALLINE

FDA Submissions

	ORIG	1	AP	1972-05-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1998-10-08

Submissions Property Types

ORIG	1	Null	0
SUPPL	4	Null	0

CDER Filings

JOHNSON AND JOHNSON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50448
            [companyName] => JOHNSON AND JOHNSON
            [docInserts] => ["",""]
            [products] => [{"drugName":"GRIFULVIN V","activeIngredients":"GRISEOFULVIN, MICROCRYSTALLINE","strength":"125MG\/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GRIFULVIN V","submission":"GRISEOFULVIN, MICROCRYSTALLINE","actionType":"125MG\/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)