Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 209266
Company: HETERO LABS LTD V

Products on ANDA 209266

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AVANAFIL	AVANAFIL	50MG	TABLET;ORAL	Prescription	AB	No	No
AVANAFIL	AVANAFIL	100MG	TABLET;ORAL	Prescription	AB	No	No
AVANAFIL	AVANAFIL	200MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209266

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/14/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 209266

AVANAFIL

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AVANAFIL	AVANAFIL	50MG	TABLET;ORAL	Prescription	No	AB	209266	HETERO LABS LTD V
STENDRA	AVANAFIL	50MG	TABLET;ORAL	Prescription	Yes	AB	202276	METUCHEN PHARMS

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AVANAFIL	AVANAFIL	100MG	TABLET;ORAL	Prescription	No	AB	209266	HETERO LABS LTD V
STENDRA	AVANAFIL	100MG	TABLET;ORAL	Prescription	Yes	AB	202276	METUCHEN PHARMS

TABLET;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AVANAFIL	AVANAFIL	200MG	TABLET;ORAL	Prescription	No	AB	209266	HETERO LABS LTD V
STENDRA	AVANAFIL	200MG	TABLET;ORAL	Prescription	Yes	AB	202276	METUCHEN PHARMS