ANDA 205670

PRINSTON INC

FDA Drug Application

Application #205670

Application Sponsors

ANDA 205670

PRINSTON INC

Marketing Status

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

Application Products

001	TABLET;ORAL	10MG	0	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM
002	TABLET;ORAL	20MG	0	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM
003	TABLET;ORAL	40MG	0	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-08-29

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

PRINSTON INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205670
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FOSINOPRIL SODIUM","activeIngredients":"FOSINOPRIL SODIUM","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FOSINOPRIL SODIUM","activeIngredients":"FOSINOPRIL SODIUM","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FOSINOPRIL SODIUM","activeIngredients":"FOSINOPRIL SODIUM","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/29\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-08-29
        )

)