ANDA 206304

COREPHARMA

FDA Drug Application

Application #206304

Application Sponsors

ANDA 206304

COREPHARMA

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003
• None (Tentative Approval): 004
• None (Tentative Approval): 005
• None (Tentative Approval): 006

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	5MG	0	DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE	DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE
002	CAPSULE, EXTENDED RELEASE;ORAL	10MG	0	DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE	DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE
003	CAPSULE, EXTENDED RELEASE;ORAL	15MG	0	DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE	DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE
004	CAPSULE, EXTENDED RELEASE;ORAL	20MG	0	DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE	DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE
005	CAPSULE, EXTENDED RELEASE;ORAL	25MG	0	DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE	DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE
006	CAPSULE, EXTENDED RELEASE;ORAL	30MG	0	DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE	DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2016-04-15

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

COREPHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206304
            [companyName] => COREPHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE","activeIngredients":"DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE","strength":"5MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE","activeIngredients":"DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE","strength":"10MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE","activeIngredients":"DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE","strength":"15MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE","activeIngredients":"DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE","strength":"20MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE","activeIngredients":"DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE","strength":"25MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE","activeIngredients":"DEXTROAMPHETAMINE SACCHARATE;AMPHETAMINE ASPARTATE MONOHYDRATE;DEXTROAMPHETAMINE SULFATE;AMPHETAMINE SULFATE","strength":"30MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/15\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-04-15
        )

)