ANDA 204590

MACLEODS PHARMS LTD

FDA Drug Application

Application #204590

Application Sponsors

ANDA 204590

MACLEODS PHARMS LTD

Marketing Status

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

Application Products

001	CAPSULE;ORAL	50MG	0	CELECOXIB	CELECOXIB
002	CAPSULE;ORAL	100MG	0	CELECOXIB	CELECOXIB
003	CAPSULE;ORAL	200MG	0	CELECOXIB	CELECOXIB
004	CAPSULE;ORAL	400MG	0	CELECOXIB	CELECOXIB

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-03-16
LABELING; Labeling	SUPPL	3	AP	2016-09-16	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	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] => 204590
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CELECOXIB","activeIngredients":"CELECOXIB","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CELECOXIB","activeIngredients":"CELECOXIB","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CELECOXIB","activeIngredients":"CELECOXIB","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CELECOXIB","activeIngredients":"CELECOXIB","strength":"400MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/16\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/16\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-09-16
        )

)