ANDA 207016

MICRO LABS

FDA Drug Application

Application #207016

Documents

• Letter: 2017-10-06

Application Sponsors

ANDA 207016

MICRO LABS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	20MG	0	TELMISARTAN	TELMISARTAN
002	TABLET;ORAL	40MG	0	TELMISARTAN	TELMISARTAN
003	TABLET;ORAL	80MG	0	TELMISARTAN	TELMISARTAN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-10-03	STANDARD
LABELING; Labeling	SUPPL	2	AP	2019-11-04	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

MICRO LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207016
            [companyName] => MICRO LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TELMISARTAN","activeIngredients":"TELMISARTAN","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TELMISARTAN","activeIngredients":"TELMISARTAN","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TELMISARTAN","activeIngredients":"TELMISARTAN","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/03\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/207016Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/04\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-11-04
        )

)