ANDA 076239

EI INC

FDA Drug Application

Application #076239

Application Sponsors

ANDA 076239

EI INC

Marketing Status

• Over-the-counter: 001

Application Products

001

SOLUTION;TOPICAL

5%

0

THEROXIDIL

MINOXIDIL

FDA Submissions

	ORIG	1	AP	2004-08-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2016-07-21
LABELING; Labeling	SUPPL	10	AP	2016-07-21

Submissions Property Types

SUPPL	8	Null	15
SUPPL	10	Null	15

CDER Filings

EI INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76239
            [companyName] => EI INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"THEROXIDIL","activeIngredients":"MINOXIDIL","strength":"5%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"THEROXIDIL","submission":"MINOXIDIL","actionType":"5%","submissionClassification":"SOLUTION;TOPICAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)