ANDA 090174

ZYDUS PHARMS USA INC

FDA Drug Application

Application #090174

Application Sponsors

ANDA 090174

ZYDUS PHARMS USA INC

Marketing Status

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

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	EQ 37.5MG BASE	0	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE
002	CAPSULE, EXTENDED RELEASE;ORAL	EQ 75MG BASE	0	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE
003	CAPSULE, EXTENDED RELEASE;ORAL	EQ 150MG BASE	0	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2011-04-14
LABELING; Labeling	SUPPL	5	AP	2012-09-19	STANDARD
LABELING; Labeling	SUPPL	8	AP	2014-01-10	STANDARD
LABELING; Labeling	SUPPL	9	AP	2016-01-20	STANDARD
LABELING; Labeling	SUPPL	11	AP	2016-01-20	STANDARD
LABELING; Labeling	SUPPL	12	AP	2016-01-20	STANDARD
LABELING; Labeling	SUPPL	14	AP	2020-11-13	STANDARD
LABELING; Labeling	SUPPL	16	AP	2020-11-13	STANDARD
LABELING; Labeling	SUPPL	18	AP	2020-11-13	STANDARD
LABELING; Labeling	SUPPL	21	AP	2020-11-13	STANDARD
LABELING; Labeling	SUPPL	27	AP	2020-11-13	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	15
SUPPL	8	Null	15
SUPPL	9	Null	7
SUPPL	11	Null	7
SUPPL	12	Null	7
SUPPL	14	Null	7
SUPPL	16	Null	7
SUPPL	18	Null	7
SUPPL	21	Null	15
SUPPL	27	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90174
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VENLAFAXINE HYDROCHLORIDE","activeIngredients":"VENLAFAXINE HYDROCHLORIDE","strength":"EQ 37.5MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VENLAFAXINE HYDROCHLORIDE","activeIngredients":"VENLAFAXINE HYDROCHLORIDE","strength":"EQ 75MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VENLAFAXINE HYDROCHLORIDE","activeIngredients":"VENLAFAXINE HYDROCHLORIDE","strength":"EQ 150MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VENLAFAXINE HYDROCHLORIDE","submission":"VENLAFAXINE HYDROCHLORIDE","actionType":"EQ 37.5MG BASE","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"VENLAFAXINE HYDROCHLORIDE","submission":"VENLAFAXINE HYDROCHLORIDE","actionType":"EQ 75MG BASE","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"VENLAFAXINE HYDROCHLORIDE","submission":"VENLAFAXINE HYDROCHLORIDE","actionType":"EQ 150MG BASE","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)