Is there a generic for Finasteride; tadalafil?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Finasteride; tadalafil, referencing the brand ENTADFI. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Finasteride; tadalafil?

ENTADFI (NDA 215423, BLUE WATER BIOTECH) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Finasteride; tadalafil are approved?

Finasteride; tadalafil is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Finasteride; tadalafil

Finasteride; tadalafil is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ENTADFI · NDA 215423

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule

Product	Applicant	Application	TE	Approved
ENTADFIRLD	BLUE WATER BIOTECH	NDA 215423	—	Dec 09, 2021

Generic (ANDA) products (2)

Product	Applicant	Application	TE	Approved
FINASTERIDE AND TADALAFIL	NOVITIUM PHARMA	ANDA 218499	—	Mar 19, 2025
FINASTERIDE AND TADALAFIL	ZYDUS LIFESCIENCES	ANDA 218232	—	Mar 15, 2024

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Finasteride; tadalafil — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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