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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205468
Company: NOSTRUM LABS INC

Products on ANDA 205468

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205468

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/24/2017	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205468Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 205468

VENLAFAXINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; EQ 150MG 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 150MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214691	AJANTA PHARMA LTD
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214127	ALKEM LABS LTD
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214609	APPCO
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214419	ASCENT PHARMS INC
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211323	CADILA PHARMS LTD
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	209193	DEXCEL
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205468	NOSTRUM LABS INC
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	022104	OSMOTICA PHARM US
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	216044	UNIQUE
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	215622	ZYDUS PHARMS

TABLET, EXTENDED RELEASE;ORAL; EQ 225MG 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 225MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214691	AJANTA PHARMA LTD
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214127	ALKEM LABS LTD
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214609	APPCO
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214419	ASCENT PHARMS INC
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211323	CADILA PHARMS LTD
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	209193	DEXCEL
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205468	NOSTRUM LABS INC
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	022104	OSMOTICA PHARM US
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	216044	UNIQUE
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	215622	ZYDUS PHARMS

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