ANDA 204172

LUPIN LTD

FDA Drug Application

Application #204172

Documents

• Letter: 2015-07-08

Application Sponsors

ANDA 204172

LUPIN LTD

Marketing Status

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

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	EQ 50MG BASE	0	DESVENLAFAXINE SUCCINATE	DESVENLAFAXINE SUCCINATE
002	TABLET, EXTENDED RELEASE;ORAL	EQ 100MG BASE	0	DESVENLAFAXINE SUCCINATE	DESVENLAFAXINE SUCCINATE
003	TABLET, EXTENDED RELEASE;ORAL	EQ 25MG BASE	0	DESVENLAFAXINE SUCCINATE	DESVENLAFAXINE SUCCINATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-06-29
LABELING; Labeling	SUPPL	20	AP	2022-04-13	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	20	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204172
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DESVENLAFAXINE SUCCINATE","activeIngredients":"DESVENLAFAXINE SUCCINATE","strength":"EQ 50MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DESVENLAFAXINE SUCCINATE","activeIngredients":"DESVENLAFAXINE SUCCINATE","strength":"EQ 100MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/29\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204172Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/15\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-07-15
        )

)