ANDA 077510

IMPAX LABS

FDA Drug Application

Application #077510

Documents

• Letter: 2006-10-26

Application Sponsors

ANDA 077510

IMPAX LABS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

1GM

0

COLESTIPOL HYDROCHLORIDE

COLESTIPOL HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2006-10-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2014-10-09

Submissions Property Types

SUPPL

8

Null

0

TE Codes

001

Prescription

AB

CDER Filings

IMPAX LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77510
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"COLESTIPOL HYDROCHLORIDE","activeIngredients":"COLESTIPOL HYDROCHLORIDE","strength":"1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"COLESTIPOL HYDROCHLORIDE","submission":"COLESTIPOL HYDROCHLORIDE","actionType":"1GM","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)