Details for New Drug Application (NDA): 218499

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NDA 218499 describes FINASTERIDE AND TADALAFIL, which is a drug marketed by Novitium Pharma and Zydus Lifesciences and is included in two NDAs. Additional details are available on the FINASTERIDE AND TADALAFIL profile page.

The generic ingredient in FINASTERIDE AND TADALAFIL 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 218499

Tradename:	FINASTERIDE AND TADALAFIL
Applicant:	Novitium Pharma
Ingredient:	finasteride; tadalafil
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	5MG;5MG
Approval Date:	Mar 19, 2025	TE:		RLD:	No

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