ANDA 077277

IMPAX LABS

FDA Drug Application

Application #077277

Documents

• Letter: 2006-05-03

Application Sponsors

ANDA 077277

IMPAX LABS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	GRANULE;ORAL	5GM/SCOOPFUL	0	COLESTIPOL HYDROCHLORIDE	COLESTIPOL HYDROCHLORIDE
002	GRANULE;ORAL	5GM/PACKET	0	COLESTIPOL HYDROCHLORIDE	COLESTIPOL HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2006-05-02

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

IMPAX LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77277
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"COLESTIPOL HYDROCHLORIDE","activeIngredients":"COLESTIPOL HYDROCHLORIDE","strength":"5GM\/SCOOPFUL","dosageForm":"GRANULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"COLESTIPOL HYDROCHLORIDE","activeIngredients":"COLESTIPOL HYDROCHLORIDE","strength":"5GM\/PACKET","dosageForm":"GRANULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"COLESTIPOL HYDROCHLORIDE","submission":"COLESTIPOL HYDROCHLORIDE","actionType":"5GM\/SCOOPFUL","submissionClassification":"GRANULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"COLESTIPOL HYDROCHLORIDE","submission":"COLESTIPOL HYDROCHLORIDE","actionType":"5GM\/PACKET","submissionClassification":"GRANULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)