NDA 012402

PROCTER AND GAMBLE

FDA Drug Application

Application #012402

Application Sponsors

NDA 012402

PROCTER AND GAMBLE

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 180MG BASE/VIAL

0

IVADANTIN

NITROFURANTOIN SODIUM

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	1960-09-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1979-06-06	STANDARD
LABELING; Labeling	SUPPL	16	AP	1979-06-06	STANDARD
LABELING; Labeling	SUPPL	17	AP	1979-07-13	STANDARD
LABELING; Labeling	SUPPL	19	AP	1982-10-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1982-04-13	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	21	Null	0

CDER Filings

PROCTER AND GAMBLE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 12402
            [companyName] => PROCTER AND GAMBLE
            [docInserts] => ["",""]
            [products] => [{"drugName":"IVADANTIN","activeIngredients":"NITROFURANTOIN SODIUM","strength":"EQ 180MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IVADANTIN","submission":"NITROFURANTOIN SODIUM","actionType":"EQ 180MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)