ANDA 078472

BRECKENRIDGE

FDA Drug Application

Application #078472

Application Sponsors

ANDA 078472

BRECKENRIDGE

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

ORIG

1

AP

2013-02-13

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

NOSTRUM LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78472
            [companyName] => NOSTRUM LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PIOGLITAZONE HYDROCHLORIDE","activeIngredients":"PIOGLITAZONE HYDROCHLORIDE","strength":"EQ 15MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PIOGLITAZONE HYDROCHLORIDE","activeIngredients":"PIOGLITAZONE HYDROCHLORIDE","strength":"EQ 30MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PIOGLITAZONE HYDROCHLORIDE","activeIngredients":"PIOGLITAZONE HYDROCHLORIDE","strength":"EQ 45MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PIOGLITAZONE HYDROCHLORIDE","submission":"PIOGLITAZONE HYDROCHLORIDE","actionType":"EQ 15MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PIOGLITAZONE HYDROCHLORIDE","submission":"PIOGLITAZONE HYDROCHLORIDE","actionType":"EQ 30MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PIOGLITAZONE HYDROCHLORIDE","submission":"PIOGLITAZONE HYDROCHLORIDE","actionType":"EQ 45MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)