ANDA 206738

PURACAP PHARM LLC

FDA Drug Application

Application #206738

Application Sponsors

ANDA 206738

PURACAP PHARM LLC

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

2017-10-06

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

PURACAP PHARM LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206738
            [companyName] => PURACAP PHARM LLC
            [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":"10\/06\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/29\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-11-29
        )

)