ANDA 073618

MAYNE PHARMA

FDA Drug Application

Application #073618

Application Sponsors

ANDA 073618

MAYNE PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

10MG;100MG

0

CARBIDOPA AND LEVODOPA

CARBIDOPA; LEVODOPA

FDA Submissions

	ORIG	1	AP	1992-08-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1996-12-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1997-10-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1999-02-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1999-02-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1999-12-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1999-12-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2002-01-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2002-01-04
LABELING; Labeling	SUPPL	15	AP	2001-11-06
LABELING; Labeling	SUPPL	22	AP	2009-10-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2011-02-03
LABELING; Labeling	SUPPL	25	AP	2011-07-05
LABELING; Labeling	SUPPL	27	AP	2015-11-05	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	22	Null	7
SUPPL	25	Null	7
SUPPL	27	Null	7

TE Codes

001

Prescription

AB

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 73618
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARBIDOPA AND LEVODOPA","activeIngredients":"CARBIDOPA; LEVODOPA","strength":"10MG;100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CARBIDOPA AND LEVODOPA","submission":"CARBIDOPA; LEVODOPA","actionType":"10MG;100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)