Documents
Application Sponsors
| NDA 205583 | SUN PHARMA GLOBAL | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | EQ 50MG BASE | 1 | DESVENLAFAXINE | DESVENLAFAXINE FUMARATE |
| 002 | TABLET, EXTENDED RELEASE;ORAL | EQ 100MG BASE | 1 | DESVENLAFAXINE | DESVENLAFAXINE FUMARATE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2014-01-28 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2014-07-18 | 901 REQUIRED |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2015-02-03 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2017-01-04 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 6 | AP | 2017-12-19 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 10 | AP | 2019-12-10 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 40 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 6 | Null | 6 |
| SUPPL | 10 | Null | 7 |
CDER Filings
SUN PHARMA GLOBAL
cder:Array
(
[0] => Array
(
[ApplNo] => 205583
[companyName] => SUN PHARMA GLOBAL
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/205583s010lbl.pdf#page=30"]
[products] => [{"drugName":"DESVENLAFAXINE","activeIngredients":"DESVENLAFAXINE FUMARATE","strength":"EQ 50MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"DESVENLAFAXINE","activeIngredients":"DESVENLAFAXINE FUMARATE","strength":"EQ 100MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"12\/10\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205583s010lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205583s006lbl.pdf\"}]","notes":""},{"actionDate":"01\/04\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205583s005lbl.pdf\"}]","notes":""},{"actionDate":"07\/18\/2014","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205583s001s003lbl.pdf\"}]","notes":""},{"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\\\/205583s001s003lbl.pdf\"}]","notes":""},{"actionDate":"01\/28\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205583s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"01\/28\/2014","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\\\/2014\\\/205583s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/205583Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/205583Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/205583Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"12\/10\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205583s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/205583Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"12\/19\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205583s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205583Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"01\/04\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205583s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205583Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"02\/03\/2015","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/18\/2014","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205583s001s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/205583Orig1s001,s003ltr.pdf\"}]","notes":">"},{"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\\\/205583s001s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/205583Orig1s001,s003ltr.pdf\"}]","notes":">"}]
[actionDate] => 2019-12-10
)
)