ANDA 211166

MACLEODS PHARMS LTD

FDA Drug Application

Application #211166

Application Sponsors

ANDA 211166

MACLEODS PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	4MG	0	SILODOSIN	SILODOSIN
002	CAPSULE;ORAL	8MG	0	SILODOSIN	SILODOSIN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-12-03	STANDARD
LABELING; Labeling	SUPPL	8	AP	2021-07-16	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	8	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211166
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"SILODOSIN","activeIngredients":"SILODOSIN","strength":"4MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SILODOSIN","activeIngredients":"SILODOSIN","strength":"8MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/03\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-12-03
        )

)