Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210014
Company: YICHANG HUMANWELL
Company: YICHANG HUMANWELL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 100MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 25MG 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 |
|---|---|---|---|---|---|---|---|
| 10/01/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/01/2023 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/21/2023 | SUPPL-14 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 02/21/2023 | SUPPL-12 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 02/21/2023 | SUPPL-10 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
DESVENLAFAXINE SUCCINATE
TABLET, EXTENDED RELEASE;ORAL; EQ 50MG 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 50MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204065 | ACTAVIS LABS FL |
| DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204003 | ALEMBIC |
| DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204083 | HIKMA |
| DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204172 | LUPIN |
| DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211427 | MACLEODS PHARMS LTD |
| DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204805 | PLATINUM |
| DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204028 | RUBICON RESEARCH |
| DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210014 | YICHANG HUMANWELL |
| DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 220460 | YICHANG HUMANWELL |
| DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204020 | ZYDUS PHARMS |
| PRISTIQ | DESVENLAFAXINE SUCCINATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021992 | PF PRISM CV |
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 | 204172 | LUPIN |
| DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 100MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211427 | MACLEODS PHARMS LTD |
| DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 100MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204805 | PLATINUM |
| DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 100MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204028 | RUBICON RESEARCH |
| 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 | 220460 | 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 |
TABLET, EXTENDED RELEASE;ORAL; EQ 25MG 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 25MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204065 | ACTAVIS LABS FL |
| DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 25MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204003 | ALEMBIC |
| DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 25MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204083 | HIKMA |
| DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 25MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204172 | LUPIN |
| DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 25MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204028 | RUBICON RESEARCH |
| DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 25MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210014 | YICHANG HUMANWELL |
| DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 25MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 220460 | YICHANG HUMANWELL |
| DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 25MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204020 | ZYDUS PHARMS |
| PRISTIQ | DESVENLAFAXINE SUCCINATE | EQ 25MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021992 | PF PRISM CV |