Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | EQ 50MG BASE | 0 | DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE |
| 002 | TABLET, EXTENDED RELEASE;ORAL | EQ 25MG BASE | 0 | DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2016-02-16 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2016-11-15 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2017-09-05 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2019-10-30 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 19 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 5 | Null | 31 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
HIKMA
cder:Array
(
[0] => Array
(
[ApplNo] => 204082
[companyName] => HIKMA
[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 25MG 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\\\/204082Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"10\/30\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/05\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/15\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-10-30
)
)