ANDA 203813

MACLEODS PHARMS LTD

FDA Drug Application

Application #203813

Application Sponsors

ANDA 203813

MACLEODS PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	4MG	0	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL
002	TABLET;ORAL	8MG	0	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL
003	TABLET;ORAL	16MG	0	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL
004	TABLET;ORAL	32MG	0	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-12-05
LABELING; Labeling	SUPPL	16	AP	2021-04-30	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	16	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203813
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CANDESARTAN CILEXETIL","activeIngredients":"CANDESARTAN CILEXETIL","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CANDESARTAN CILEXETIL","activeIngredients":"CANDESARTAN CILEXETIL","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CANDESARTAN CILEXETIL","activeIngredients":"CANDESARTAN CILEXETIL","strength":"16MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CANDESARTAN CILEXETIL","activeIngredients":"CANDESARTAN CILEXETIL","strength":"32MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/05\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/19\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-07-19
        )

)