ANDA 208441

MYLAN

FDA Drug Application

Application #208441

Documents

• REMS: 2019-04-01
• Letter: 2019-04-24

Application Sponsors

ANDA 208441

MYLAN

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	5MG	0	AMBRISENTAN	AMBRISENTAN
002	TABLET;ORAL	10MG	0	AMBRISENTAN	AMBRISENTAN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-03-28	STANDARD
REMS; REMS	SUPPL	2	AP	2020-12-22
REMS; REMS	SUPPL	3	AP	2021-06-08

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	3	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

MYLAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208441
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMBRISENTAN","activeIngredients":"AMBRISENTAN","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMBRISENTAN","activeIngredients":"AMBRISENTAN","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/28\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208441Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/06\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-11-06
        )

)