NDA 019369

ROCHE

FDA Drug Application

Application #019369

Documents

• Review: 2019-02-15

Application Sponsors

NDA 019369

ROCHE

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	CAPSULE;ORAL	10MG	0	TEGISON	ETRETINATE
002	CAPSULE;ORAL	25MG	0	TEGISON	ETRETINATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1986-09-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1987-04-02	PRIORITY
LABELING; Labeling	SUPPL	3	AP	1988-05-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1988-03-25	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1988-08-05	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1988-08-31	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1990-10-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1991-10-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1994-01-12	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1995-02-16	PRIORITY

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19369
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TEGISON","activeIngredients":"ETRETINATE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TEGISON","activeIngredients":"ETRETINATE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TEGISON","submission":"ETRETINATE","actionType":"10MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TEGISON","submission":"ETRETINATE","actionType":"25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)