ANDA 202180

TORRENT

FDA Drug Application

Application #202180

Application Sponsors

ANDA 202180

TORRENT

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

N/A; Not Applicable	ORIG	1	AP	2013-11-27
LABELING; Labeling	SUPPL	2	AP	2014-06-26	STANDARD
LABELING; Labeling	SUPPL	3	AP	2014-07-18	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	2	Null	7
SUPPL	3	Null	7

TE Codes

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

CDER Filings

TORRENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202180
            [companyName] => TORRENT
            [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":"11\/27\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/18\/2014","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/26\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2014-07-18
        )

)