ANDA 202467

MACLEODS PHARMS LTD

FDA Drug Application

Application #202467

Documents

• Letter: 2013-02-08

Application Sponsors

ANDA 202467

MACLEODS PHARMS LTD

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	2013-02-06
LABELING; Labeling	SUPPL	4	AP	2016-01-26	STANDARD
LABELING; Labeling	SUPPL	9	AP	2018-12-17	STANDARD
LABELING; Labeling	SUPPL	12	AP	2018-12-17	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	15
SUPPL	9	Null	15
SUPPL	12	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202467
            [companyName] => MACLEODS PHARMS LTD
            [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":"02\/06\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/202467Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/17\/2018","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/17\/2018","submission":"SUPPL-9","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/26\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels, Labeling-Medication Guide, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-12-17
        )

)