Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214031
Company: ALEMBIC

Products on ANDA 214031

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	AB	No	No
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	AB	No	No
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	AB	No	No
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214031

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/04/2020	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
06/30/2023	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 214031

VARDENAFIL HYDROCHLORIDE

TABLET;ORAL; EQ 2.5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	214031	ALEMBIC
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	209057	CROSSMEDIKA SA
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	204632	MACLEODS PHARMS LTD
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	091347	TEVA PHARMS
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	208960	ZYDUS PHARMS

TABLET;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	214031	ALEMBIC
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	209057	CROSSMEDIKA SA
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	204632	MACLEODS PHARMS LTD
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	091347	TEVA PHARMS
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	208960	ZYDUS PHARMS

TABLET;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	214031	ALEMBIC
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	209057	CROSSMEDIKA SA
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	204632	MACLEODS PHARMS LTD
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	091347	TEVA PHARMS
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	208960	ZYDUS PHARMS

TABLET;ORAL; EQ 20MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	214031	ALEMBIC
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	209057	CROSSMEDIKA SA
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	204632	MACLEODS PHARMS LTD
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	091347	TEVA PHARMS
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	208960	ZYDUS PHARMS