Details for New Drug Application (NDA): 215423

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NDA 215423 describes ENTADFI, which is a drug marketed by Blue Water Biotech and is included in one NDA. Additional details are available on the ENTADFI profile page.

The generic ingredient in ENTADFI is finasteride; tadalafil. There are fourteen drug master file entries for this compound. Additional details are available on the finasteride; tadalafil profile page.

Summary for 215423

Tradename:	ENTADFI
Applicant:	Blue Water Biotech
Ingredient:	finasteride; tadalafil
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	5MG;5MG
Approval Date:	Dec 9, 2021	TE:		RLD:	Yes

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