ANDA 210609

PRINSTON INC

FDA Drug Application

Application #210609

Application Sponsors

ANDA 210609

PRINSTON INC

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

2022-08-11

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

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

CDER Filings

PRINSTON INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210609
            [companyName] => PRINSTON INC
            [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":"08\/11\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-11
        )

)