Drugs@FDA: FDA-Approved Drugs

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

Products on ANDA 204003

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204003

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
01/23/2023	SUPPL-20	Labeling-Medication Guide, Labeling-Package Insert		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.

Therapeutic Equivalents for ANDA 204003

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