NDA 009660

ROCHE

FDA Drug Application

Application #009660

Application Sponsors

NDA 009660

ROCHE

Marketing Status

• Discontinued: 002
• Discontinued: 004
• Discontinued: 007
• Discontinued: 008

Application Products

002	TABLET;ORAL	50MG	0	NOLUDAR	METHYPRYLON
004	TABLET;ORAL	200MG	0	NOLUDAR	METHYPRYLON
007	ELIXIR;ORAL	50MG/5ML	0	NOLUDAR	METHYPRYLON
008	CAPSULE;ORAL	300MG	0	NOLUDAR	METHYPRYLON

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1955-01-18	STANDARD
LABELING; Labeling	SUPPL	7	AP	1977-06-23
LABELING; Labeling	SUPPL	8	AP	1977-06-23
LABELING; Labeling	SUPPL	9	AP	1996-04-26
LABELING; Labeling	SUPPL	10	AP	1978-10-27
LABELING; Labeling	SUPPL	12	AP	1979-03-21
LABELING; Labeling	SUPPL	13	AP	1980-12-15
LABELING; Labeling	SUPPL	14	AP	1982-02-26
LABELING; Labeling	SUPPL	16	AP	1986-08-27

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 9660
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"NOLUDAR","activeIngredients":"METHYPRYLON","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NOLUDAR","activeIngredients":"METHYPRYLON","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NOLUDAR","activeIngredients":"METHYPRYLON","strength":"50MG\/5ML","dosageForm":"ELIXIR;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NOLUDAR","activeIngredients":"METHYPRYLON","strength":"300MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NOLUDAR","submission":"METHYPRYLON","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NOLUDAR","submission":"METHYPRYLON","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NOLUDAR","submission":"METHYPRYLON","actionType":"50MG\/5ML","submissionClassification":"ELIXIR;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NOLUDAR","submission":"METHYPRYLON","actionType":"300MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)