ANDA 077584

ZYDUS PHARMS USA

FDA Drug Application

Application #077584

Application Sponsors

ANDA 077584

ZYDUS PHARMS USA

Marketing Status

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

Application Products

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

FDA Submissions

	ORIG	1	AP	2007-03-07
LABELING; Labeling	SUPPL	2	AP	2008-05-20
LABELING; Labeling	SUPPL	7	AP	2008-05-29
LABELING; Labeling	SUPPL	9	AP	2009-04-29
LABELING; Labeling	SUPPL	10	AP	2009-04-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2011-01-30
LABELING; Labeling	SUPPL	15	AP	2010-10-15
LABELING; Labeling	SUPPL	17	AP	2011-03-04
LABELING; Labeling	SUPPL	18	AP	2011-07-27
LABELING; Labeling	SUPPL	19	AP	2012-07-31
LABELING; Labeling	SUPPL	22	AP	2013-08-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2014-11-26
LABELING; Labeling	SUPPL	25	AP	2013-08-19	STANDARD
LABELING; Labeling	SUPPL	27	AP	2015-01-19	STANDARD
LABELING; Labeling	SUPPL	28	AP	2020-03-19	STANDARD
LABELING; Labeling	SUPPL	29	AP	2020-03-19	STANDARD
LABELING; Labeling	SUPPL	34	AP	2022-02-25	STANDARD
LABELING; Labeling	SUPPL	35	AP	2022-02-25	STANDARD

Submissions Property Types

SUPPL	13	Null	8
SUPPL	19	Null	15
SUPPL	22	Null	15
SUPPL	23	Null	8
SUPPL	25	Null	15
SUPPL	27	Null	7
SUPPL	28	Null	7
SUPPL	29	Null	15
SUPPL	34	Null	15
SUPPL	35	Null	15

TE Codes

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

CDER Filings

ZYDUS PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77584
            [companyName] => ZYDUS PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PAROXETINE HYDROCHLORIDE","activeIngredients":"PAROXETINE HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PAROXETINE HYDROCHLORIDE","activeIngredients":"PAROXETINE HYDROCHLORIDE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PAROXETINE HYDROCHLORIDE","activeIngredients":"PAROXETINE HYDROCHLORIDE","strength":"EQ 30MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PAROXETINE HYDROCHLORIDE","activeIngredients":"PAROXETINE HYDROCHLORIDE","strength":"EQ 40MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PAROXETINE HYDROCHLORIDE","submission":"PAROXETINE HYDROCHLORIDE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PAROXETINE HYDROCHLORIDE","submission":"PAROXETINE HYDROCHLORIDE","actionType":"EQ 20MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PAROXETINE HYDROCHLORIDE","submission":"PAROXETINE HYDROCHLORIDE","actionType":"EQ 30MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PAROXETINE HYDROCHLORIDE","submission":"PAROXETINE HYDROCHLORIDE","actionType":"EQ 40MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)