ANDA 077653

ZYDUS PHARMS USA

FDA Drug Application

Application #077653

Application Sponsors

ANDA 077653

ZYDUS PHARMS USA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005

Application Products

001	TABLET;ORAL	EQ 25MG BASE	0	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE
002	TABLET;ORAL	EQ 37.5MG BASE	0	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE
003	TABLET;ORAL	EQ 50MG BASE	0	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE
004	TABLET;ORAL	EQ 75MG BASE	0	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE
005	TABLET;ORAL	EQ 100MG BASE	0	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2008-06-13
LABELING; Labeling	SUPPL	3	AP	2010-03-11
LABELING; Labeling	SUPPL	4	AP	2012-09-19	STANDARD
LABELING; Labeling	SUPPL	6	AP	2014-06-17	STANDARD
LABELING; Labeling	SUPPL	9	AP	2014-07-18	STANDARD
LABELING; Labeling	SUPPL	13	AP	2016-11-25	STANDARD
LABELING; Labeling	SUPPL	14	AP	2017-01-04	STANDARD
LABELING; Labeling	SUPPL	20	AP	2020-04-14	STANDARD
LABELING; Labeling	SUPPL	22	AP	2021-09-21	STANDARD

Submissions Property Types

SUPPL	3	Null	7
SUPPL	4	Null	15
SUPPL	6	Null	15
SUPPL	9	Null	7
SUPPL	13	Null	15
SUPPL	14	Null	15
SUPPL	20	Null	7
SUPPL	22	Null	7

TE Codes

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

CDER Filings

ZYDUS PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77653
            [companyName] => ZYDUS PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"VENLAFAXINE HYDROCHLORIDE","activeIngredients":"VENLAFAXINE HYDROCHLORIDE","strength":"EQ 25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VENLAFAXINE HYDROCHLORIDE","activeIngredients":"VENLAFAXINE HYDROCHLORIDE","strength":"EQ 37.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VENLAFAXINE HYDROCHLORIDE","activeIngredients":"VENLAFAXINE HYDROCHLORIDE","strength":"EQ 50MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VENLAFAXINE HYDROCHLORIDE","activeIngredients":"VENLAFAXINE HYDROCHLORIDE","strength":"EQ 75MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VENLAFAXINE HYDROCHLORIDE","activeIngredients":"VENLAFAXINE HYDROCHLORIDE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VENLAFAXINE HYDROCHLORIDE","submission":"VENLAFAXINE HYDROCHLORIDE","actionType":"EQ 25MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"VENLAFAXINE HYDROCHLORIDE","submission":"VENLAFAXINE HYDROCHLORIDE","actionType":"EQ 37.5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"VENLAFAXINE HYDROCHLORIDE","submission":"VENLAFAXINE HYDROCHLORIDE","actionType":"EQ 50MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"VENLAFAXINE HYDROCHLORIDE","submission":"VENLAFAXINE HYDROCHLORIDE","actionType":"EQ 75MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"VENLAFAXINE HYDROCHLORIDE","submission":"VENLAFAXINE HYDROCHLORIDE","actionType":"EQ 100MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)