ANDA 201466

BRECKENRIDGE

FDA Drug Application

Application #201466

Application Sponsors

ANDA 201466

BRECKENRIDGE

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION;ORAL	5MG/5ML	0	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE
002	SOLUTION;ORAL	10MG/5ML	0	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2013-11-12

Submissions Property Types

ORIG

1

Null

1

TE Codes

001	Prescription	AA
002	Prescription	AA

CDER Filings

BRECKENRIDGE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201466
            [companyName] => BRECKENRIDGE
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"5MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"10MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/12\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-11-12
        )

)