NDA 012885

LUNDBECK INC

FDA Drug Application

Application #012885

Documents

• Letter: 2003-11-25

Application Sponsors

NDA 012885

LUNDBECK INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

2MG

1

WINSTROL

STANOZOLOL

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1962-01-09	STANDARD
EFFICACY; Efficacy	SUPPL	25	AP	1984-05-14	STANDARD
LABELING; Labeling	SUPPL	30	AP	1986-05-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1987-03-10	STANDARD
LABELING; Labeling	SUPPL	32	AP	1987-02-24	STANDARD
LABELING; Labeling	SUPPL	33	AP	1988-05-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1994-04-07	STANDARD
LABELING; Labeling	SUPPL	35	AP	1991-12-13	STANDARD
LABELING; Labeling	SUPPL	36	AP	1992-02-27	STANDARD
LABELING; Labeling	SUPPL	37	AP	2003-11-17	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	25	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0

CDER Filings

LUNDBECK INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 12885
            [companyName] => LUNDBECK INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"WINSTROL","activeIngredients":"STANOZOLOL","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"WINSTROL","submission":"STANOZOLOL","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)