NDA 019919

MEDA PHARMS

FDA Drug Application

Application #019919

Documents

• Review: 1997-08-08

Application Sponsors

NDA 019919

MEDA PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

SUPPOSITORY;RECTAL

500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

ROWASA

MESALAMINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1990-12-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1997-08-08	STANDARD
LABELING; Labeling	SUPPL	4	AP	2001-10-01	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0

CDER Filings

MEDA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19919
            [companyName] => MEDA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROWASA","activeIngredients":"MESALAMINE","strength":"500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"SUPPOSITORY;RECTAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ROWASA","submission":"MESALAMINE","actionType":"500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"SUPPOSITORY;RECTAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)