ANDA 207806

PRINSTON INC

FDA Drug Application

Application #207806

Application Sponsors

ANDA 207806

PRINSTON INC

Marketing Status

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

Application Products

001	TABLET;ORAL	EQ 15MG BASE	0	PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE
002	TABLET;ORAL	EQ 30MG BASE	0	PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE
003	TABLET;ORAL	EQ 45MG BASE	0	PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-04-17

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] => 207806
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PIOGLITAZONE HYDROCHLORIDE","activeIngredients":"PIOGLITAZONE HYDROCHLORIDE","strength":"EQ 15MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PIOGLITAZONE HYDROCHLORIDE","activeIngredients":"PIOGLITAZONE HYDROCHLORIDE","strength":"EQ 30MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PIOGLITAZONE HYDROCHLORIDE","activeIngredients":"PIOGLITAZONE HYDROCHLORIDE","strength":"EQ 45MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/17\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-04-17
        )

)