Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 205988
Company: MACLEODS PHARMS LTD

Products on ANDA 205988

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205988

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/10/2020	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
10/30/2023	SUPPL-7	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205988

VARDENAFIL HYDROCHLORIDE

TABLET, ORALLY DISINTEGRATING;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	208324	ALEMBIC
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	205988	MACLEODS PHARMS LTD