ANDA 204083

HIKMA

FDA Drug Application

Application #204083

Documents

• Letter: 2016-02-18

Application Sponsors

ANDA 204083

HIKMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

EQ 100MG BASE

0

DESVENLAFAXINE SUCCINATE

DESVENLAFAXINE SUCCINATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-02-16
LABELING; Labeling	SUPPL	2	AP	2017-09-05	STANDARD
LABELING; Labeling	SUPPL	4	AP	2019-10-30	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	2	Null	15
SUPPL	4	Null	31

TE Codes

001

Prescription

AB

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204083
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"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":"02\/16\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204083Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/30\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/05\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/06\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-30
        )

)