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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213927
Company: DEXCEL

Products on ANDA 213927

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213927

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/21/2021	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
01/03/2024	SUPPL-3	Labeling-Medication Guide, Labeling-Patient Package Insert		Label is not available on this site.
12/13/2022	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 213927

VENLAFAXINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; EQ 75MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214691	AJANTA PHARMA LTD
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214127	ALKEM LABS LTD
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214419	ASCENT PHARMS INC
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211323	CADILA PHARMS LTD
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213927	DEXCEL
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	022104	OSMOTICA PHARM US
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	091272	SUN PHARM
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	216044	UNIQUE
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	215622	ZYDUS PHARMS

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