ANDA 078176

EI INC

FDA Drug Application

Application #078176

Application Sponsors

ANDA 078176

EI INC

Marketing Status

• Over-the-counter: 001

Application Products

001

SOLUTION;TOPICAL

2%

0

THEROXIDIL

MINOXIDIL

FDA Submissions

	ORIG	1	AP	2007-11-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2016-07-21

Submissions Property Types

SUPPL

6

Null

15

CDER Filings

EI INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78176
            [companyName] => EI INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"THEROXIDIL","activeIngredients":"MINOXIDIL","strength":"2%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"THEROXIDIL","submission":"MINOXIDIL","actionType":"2%","submissionClassification":"SOLUTION;TOPICAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)