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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204083
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
DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE EQ 25MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE EQ 50MG 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
09/04/2024 SUPPL-10 Labeling-Package Insert

Label is not available on this site.
09/04/2024 SUPPL-7 Labeling-Package Insert

Label is not available on this site.
09/04/2024 SUPPL-6 Labeling-Package Insert

Label is not available on this site.
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 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

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
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