ANDA 209074

TARO

FDA Drug Application

Application #209074

Documents

• Letter: 2019-01-22
• Letter: 2019-04-11

Application Sponsors

ANDA 209074

TARO

Marketing Status

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

Application Products

001	AEROSOL, FOAM;TOPICAL	5%	0	MINOXIDIL (FOR MEN)	MINOXIDIL
002	AEROSOL, FOAM;TOPICAL	5%	0	MINOXIDIL (FOR WOMEN)	MINOXIDIL

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-12-31	STANDARD
UNKNOWN;	ORIG	2	AP	2019-04-22	STANDARD

Submissions Property Types

ORIG	1	Null	7
ORIG	2	Null	7

CDER Filings

TARO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209074
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"MINOXIDIL (FOR MEN)","activeIngredients":"MINOXIDIL","strength":"5%","dosageForm":"AEROSOL, FOAM;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"MINOXIDIL (FOR WOMEN)","activeIngredients":"MINOXIDIL","strength":"5%","dosageForm":"AEROSOL, FOAM;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/22\/2019","submission":"ORIG-2","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209074Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"12\/31\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209074Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/04\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/04\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-12-04
        )

)