ANDA 208605

CADILA PHARMS LTD

FDA Drug Application

Application #208605

Documents

• Letter: 2017-07-28

Application Sponsors

ANDA 208605

CADILA PHARMS LTD

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

2017-07-25

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

CADILA PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208605
            [companyName] => CADILA PHARMS LTD
            [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":"07\/25\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208605Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/17\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-05-17
        )

)