ANDA 211323

CADILA PHARMS LTD

FDA Drug Application

Application #211323

Application Sponsors

ANDA 211323

CADILA PHARMS LTD

Marketing Status

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

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	EQ 75MG BASE	0	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	EQ 150MG BASE	0	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE
003	TABLET, EXTENDED RELEASE;ORAL	EQ 225MG BASE	0	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-08-29	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-11-21	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

CADILA PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211323
            [companyName] => CADILA PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"VENLAFAXINE HYDROCHLORIDE","activeIngredients":"VENLAFAXINE HYDROCHLORIDE","strength":"EQ 75MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VENLAFAXINE HYDROCHLORIDE","activeIngredients":"VENLAFAXINE HYDROCHLORIDE","strength":"EQ 150MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VENLAFAXINE HYDROCHLORIDE","activeIngredients":"VENLAFAXINE HYDROCHLORIDE","strength":"EQ 225MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/29\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-08-29
        )

)