ANDA 065044

MAYNE PHARMA

FDA Drug Application

Application #065044

Documents

• Letter: 2000-12-20

Application Sponsors

ANDA 065044

MAYNE PHARMA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	100MG	0	CYCLOSPORINE	CYCLOSPORINE
002	CAPSULE;ORAL	25MG	0	CYCLOSPORINE	CYCLOSPORINE

FDA Submissions

	ORIG	1	AP	2000-12-20
LABELING; Labeling	SUPPL	2	AP	2002-05-03
LABELING; Labeling	SUPPL	3	AP	2004-05-14
LABELING; Labeling	SUPPL	4	AP	2004-12-02
LABELING; Labeling	SUPPL	8	AP	2007-02-05
LABELING; Labeling	SUPPL	10	AP	2007-11-16
LABELING; Labeling	SUPPL	17	AP	2015-01-20	STANDARD

Submissions Property Types

SUPPL

17

Null

7

TE Codes

001	Prescription	AB1
002	Prescription	AB1

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65044
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYCLOSPORINE","activeIngredients":"CYCLOSPORINE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CYCLOSPORINE","activeIngredients":"CYCLOSPORINE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CYCLOSPORINE","submission":"CYCLOSPORINE","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CYCLOSPORINE","submission":"CYCLOSPORINE","actionType":"25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)