ANDA 076798

CELLTRION

FDA Drug Application

Application #076798

Documents

• Letter: 2012-08-23
• Other Important Information from FDA: 2009-11-12

Application Sponsors

ANDA 076798

CELLTRION

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	2012-10-26
LABELING; Labeling	SUPPL	2	AP	2015-04-22	STANDARD
LABELING; Labeling	SUPPL	3	AP	2018-11-26	STANDARD
LABELING; Labeling	SUPPL	4	AP	2018-11-26	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

CELLTRION

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76798
            [companyName] => CELLTRION
            [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":"PIOGLITAZONE HYDROCHLORIDE","submission":"PIOGLITAZONE HYDROCHLORIDE","actionType":"EQ 15MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PIOGLITAZONE HYDROCHLORIDE","submission":"PIOGLITAZONE HYDROCHLORIDE","actionType":"EQ 30MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PIOGLITAZONE HYDROCHLORIDE","submission":"PIOGLITAZONE HYDROCHLORIDE","actionType":"EQ 45MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)