ANDA 090514

MYLAN PHARMS INC

FDA Drug Application

Application #090514

Application Sponsors

ANDA 090514

MYLAN PHARMS INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004

Application Products

001	TABLET;ORAL	50MG	0	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE
002	TABLET;ORAL	100MG	0	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE
003	TABLET;ORAL	150MG	0	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE
004	TABLET;ORAL	300MG	0	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2009-06-02
LABELING; Labeling	SUPPL	3	AP	2014-07-01	STANDARD
LABELING; Labeling	SUPPL	4	AP	2014-07-17	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-05-18	STANDARD

Submissions Property Types

SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	6	Null	7

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90514
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRAZODONE HYDROCHLORIDE","activeIngredients":"TRAZODONE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TRAZODONE HYDROCHLORIDE","activeIngredients":"TRAZODONE HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TRAZODONE HYDROCHLORIDE","activeIngredients":"TRAZODONE HYDROCHLORIDE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TRAZODONE HYDROCHLORIDE","activeIngredients":"TRAZODONE HYDROCHLORIDE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRAZODONE HYDROCHLORIDE","submission":"TRAZODONE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TRAZODONE HYDROCHLORIDE","submission":"TRAZODONE HYDROCHLORIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TRAZODONE HYDROCHLORIDE","submission":"TRAZODONE HYDROCHLORIDE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TRAZODONE HYDROCHLORIDE","submission":"TRAZODONE HYDROCHLORIDE","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)