ANDA 203854

PRINSTON INC

FDA Drug Application

Application #203854

Application Sponsors

ANDA 203854

PRINSTON INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	EQ 10MG BASE	0	PAROXETINE	PAROXETINE HYDROCHLORIDE
002	TABLET;ORAL	EQ 20MG BASE	0	PAROXETINE	PAROXETINE HYDROCHLORIDE
003	TABLET;ORAL	EQ 30MG BASE	0	PAROXETINE	PAROXETINE HYDROCHLORIDE
004	TABLET;ORAL	EQ 40MG BASE	0	PAROXETINE	PAROXETINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2014-10-31

Submissions Property Types

ORIG

1

Null

7

TE Codes

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

CDER Filings

PRINSTON INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203854
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PAROXETINE","activeIngredients":"PAROXETINE HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PAROXETINE","activeIngredients":"PAROXETINE HYDROCHLORIDE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PAROXETINE","activeIngredients":"PAROXETINE HYDROCHLORIDE","strength":"EQ 30MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PAROXETINE","activeIngredients":"PAROXETINE HYDROCHLORIDE","strength":"EQ 40MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/31\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/29\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-04-29
        )

)