ANDA 075357

L PERRIGO CO

FDA Drug Application

Application #075357

Documents

• Letter: 1999-07-30
• Review: 2015-07-21

Application Sponsors

ANDA 075357

L PERRIGO CO

Marketing Status

• Over-the-counter: 001
• Over-the-counter: 002

Application Products

001	SOLUTION;TOPICAL	2%	0	MINOXIDIL (FOR MEN)	MINOXIDIL
002	SOLUTION;TOPICAL	2%	0	MINOXIDIL (FOR WOMEN)	MINOXIDIL

FDA Submissions

	ORIG	1	AP	1999-07-30
LABELING; Labeling	SUPPL	5	AP	2005-07-14
LABELING; Labeling	SUPPL	14	AP	2008-10-08
LABELING; Labeling	SUPPL	24	AP	2016-03-30	STANDARD

Submissions Property Types

SUPPL

24

Null

15

CDER Filings

L PERRIGO CO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75357
            [companyName] => L PERRIGO CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"MINOXIDIL (FOR MEN)","activeIngredients":"MINOXIDIL","strength":"2%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"MINOXIDIL (FOR WOMEN)","activeIngredients":"MINOXIDIL","strength":"2%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MINOXIDIL (FOR MEN)","submission":"MINOXIDIL","actionType":"2%","submissionClassification":"SOLUTION;TOPICAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"},{"actionDate":"MINOXIDIL (FOR WOMEN)","submission":"MINOXIDIL","actionType":"2%","submissionClassification":"SOLUTION;TOPICAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)