NDA 205208

TEVA PHARMS USA

FDA Drug Application

Application #205208

Documents

• Label: 2013-10-17
• Label: 2014-07-29
• Review: 2014-03-26
• Summary Review: 2014-03-26
• Letter: 2013-10-16
• Letter: 2014-07-25
• Medication Guide: 2013-10-24

Application Sponsors

NDA 205208

TEVA PHARMS USA

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	EQ 50MG BASE	0	DESVENLAFAXINE	DESVENLAFAXINE FUMARATE
002	TABLET, EXTENDED RELEASE;ORAL	EQ 100MG BASE	0	DESVENLAFAXINE	DESVENLAFAXINE FUMARATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2013-10-11

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

TEVA PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205208
            [companyName] => TEVA PHARMS USA
            [docInserts] => ["Medication Guide",""]
            [products] => [{"drugName":"DESVENLAFAXINE","activeIngredients":"DESVENLAFAXINE FUMARATE","strength":"EQ 50MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DESVENLAFAXINE","activeIngredients":"DESVENLAFAXINE FUMARATE","strength":"EQ 100MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/18\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205208Orig1s001lbl.pdf\"}]","notes":""},{"actionDate":"10\/11\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/205208s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/11\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/205208s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/205208Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/205208Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/205208Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"07\/18\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205208Orig1s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/205208Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2014-07-18
        )

)