ANDA 076751

PERRIGO ISRAEL

FDA Drug Application

Application #076751

Documents

• Review: 2007-04-02
• Letter: 2004-09-17

Application Sponsors

ANDA 076751

PERRIGO ISRAEL

Marketing Status

• Prescription: 001

Application Products

001

ENEMA;RECTAL

4GM/60ML

0

MESALAMINE

MESALAMINE

FDA Submissions

	ORIG	1	AP	2004-09-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2007-05-22
LABELING; Labeling	SUPPL	6	AP	2007-03-16

Submissions Property Types

SUPPL

5

Null

0

TE Codes

001

Prescription

AB

CDER Filings

PERRIGO ISRAEL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76751
            [companyName] => PERRIGO ISRAEL
            [docInserts] => ["",""]
            [products] => [{"drugName":"MESALAMINE","activeIngredients":"MESALAMINE","strength":"4GM\/60ML","dosageForm":"ENEMA;RECTAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MESALAMINE","submission":"MESALAMINE","actionType":"4GM\/60ML","submissionClassification":"ENEMA;RECTAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)