NDA 018361

EMD SERONO

FDA Drug Application

Application #018361

Application Sponsors

NDA 018361

EMD SERONO

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

50MG

0

SEROPHENE

CLOMIPHENE CITRATE

FDA Submissions

	ORIG	1	AP	1982-03-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1994-12-30
LABELING; Labeling	SUPPL	24	AP	1996-04-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2001-02-01
LABELING; Labeling	SUPPL	27	AP	2001-08-14
LABELING; Labeling	SUPPL	28	AP	2002-08-13
LABELING; Labeling	SUPPL	29	AP	2003-07-31

Submissions Property Types

SUPPL	1	Null	0
SUPPL	22	Null	0
SUPPL	26	Null	0

CDER Filings

EMD SERONO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18361
            [companyName] => EMD SERONO
            [docInserts] => ["",""]
            [products] => [{"drugName":"SEROPHENE","activeIngredients":"CLOMIPHENE CITRATE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SEROPHENE","submission":"CLOMIPHENE CITRATE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)