ANDA 206250

CADILA PHARMS LTD

FDA Drug Application

Application #206250

Application Sponsors

ANDA 206250

CADILA PHARMS LTD

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

UNKNOWN;	ORIG	1	AP	2018-11-21	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-09-20	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

TE Codes

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

CDER Filings

CADILA PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206250
            [companyName] => CADILA PHARMS LTD
            [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":"11\/21\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-11-21
        )

)