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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204003
Company: ALEMBIC

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
06/29/2015 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204003Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/16/2024 SUPPL-26 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.
01/23/2023 SUPPL-20 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
01/23/2023 SUPPL-19 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
03/04/2019 SUPPL-6 Labeling-Package Insert

Label is not available on this site.
04/27/2017 SUPPL-4 Labeling-Package Insert

Label is not available on this site.
04/27/2017 SUPPL-3 Labeling-Medication Guide, 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 204082 HIKMA
DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE EQ 50MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204805 INTELLIPHARMACEUTICS
DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE EQ 50MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204172 LUPIN LTD
DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE EQ 50MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204028 RUBICON
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 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 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

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 204082 HIKMA
DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE EQ 25MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204172 LUPIN LTD
DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE EQ 25MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204028 RUBICON
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 204020 ZYDUS PHARMS
PRISTIQ DESVENLAFAXINE SUCCINATE EQ 25MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021992 PF PRISM CV
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