ANDA 204852

AUROLIFE PHARMA LLC

FDA Drug Application

Application #204852

Application Sponsors

ANDA 204852

AUROLIFE PHARMA LLC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 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

UNKNOWN;

ORIG

1

AP

2020-02-05

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

AUROLIFE PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204852
            [companyName] => AUROLIFE PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRAZODONE HYDROCHLORIDE","activeIngredients":"TRAZODONE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TRAZODONE HYDROCHLORIDE","activeIngredients":"TRAZODONE HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TRAZODONE HYDROCHLORIDE","activeIngredients":"TRAZODONE HYDROCHLORIDE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TRAZODONE HYDROCHLORIDE","activeIngredients":"TRAZODONE HYDROCHLORIDE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/05\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-02-05
        )

)