ANDA 209539

CIPLA

FDA Drug Application

Application #209539

Documents

• Letter: 2018-11-16

Application Sponsors

ANDA 209539

CIPLA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	2.5MG	0	TADALAFIL	TADALAFIL
002	TABLET;ORAL	5MG	0	TADALAFIL	TADALAFIL
003	TABLET;ORAL	10MG	0	TADALAFIL	TADALAFIL
004	TABLET;ORAL	20MG	0	TADALAFIL	TADALAFIL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-03-26

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB1

CDER Filings

CIPLA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209539
            [companyName] => CIPLA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TADALAFIL","activeIngredients":"TADALAFIL","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TADALAFIL","activeIngredients":"TADALAFIL","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TADALAFIL","activeIngredients":"TADALAFIL","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TADALAFIL","activeIngredients":"TADALAFIL","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/26\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209539Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-03-26
        )

)