ANDA 076137

MAYNE PHARMA

FDA Drug Application

Application #076137

Application Sponsors

ANDA 076137

MAYNE PHARMA

Marketing Status

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

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	5MG	0	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE
002	CAPSULE, EXTENDED RELEASE;ORAL	10MG	0	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE
003	CAPSULE, EXTENDED RELEASE;ORAL	15MG	0	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE

FDA Submissions

	ORIG	1	AP	2002-01-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-11-05
LABELING; Labeling	SUPPL	6	AP	2007-03-23
LABELING; Labeling	SUPPL	7	AP	2007-08-31
LABELING; Labeling	SUPPL	10	AP	2011-10-13
LABELING; Labeling	SUPPL	13	AP	2014-01-28	STANDARD
LABELING; Labeling	SUPPL	14	AP	2015-03-02	STANDARD
LABELING; Labeling	SUPPL	17	AP	2015-12-28	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	10	Null	15
SUPPL	13	Null	15
SUPPL	14	Null	7
SUPPL	17	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76137
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXTROAMPHETAMINE SULFATE","activeIngredients":"DEXTROAMPHETAMINE SULFATE","strength":"5MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXTROAMPHETAMINE SULFATE","activeIngredients":"DEXTROAMPHETAMINE SULFATE","strength":"10MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXTROAMPHETAMINE SULFATE","activeIngredients":"DEXTROAMPHETAMINE SULFATE","strength":"15MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DEXTROAMPHETAMINE SULFATE","submission":"DEXTROAMPHETAMINE SULFATE","actionType":"5MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DEXTROAMPHETAMINE SULFATE","submission":"DEXTROAMPHETAMINE SULFATE","actionType":"10MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DEXTROAMPHETAMINE SULFATE","submission":"DEXTROAMPHETAMINE SULFATE","actionType":"15MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)