Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204083
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 100MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
02/16/2016 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204083Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/30/2019 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
09/05/2017 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
01/06/2017 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
DESVENLAFAXINE SUCCINATE
TABLET, EXTENDED RELEASE;ORAL; EQ 100MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 100MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204065 | ACTAVIS LABS FL |
DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 100MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204003 | ALEMBIC |
DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 100MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204083 | HIKMA |
DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 100MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204805 | INTELLIPHARMACEUTICS |
DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 100MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204172 | LUPIN LTD |
DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 100MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204028 | RUBICON |
DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 100MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210014 | YICHANG HUMANWELL |
DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 100MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204020 | ZYDUS PHARMS |
PRISTIQ | DESVENLAFAXINE SUCCINATE | EQ 100MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021992 | PF PRISM CV |