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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 021319

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NDA 021319 describes AVODART, which is a drug marketed by Waylis Therap and is included in one NDA. It is available from one supplier. Additional details are available on the AVODART profile page.

The generic ingredient in AVODART is dutasteride. There are eighteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the dutasteride profile page.

Summary for 021319

Tradename:	AVODART
Applicant:	Waylis Therap
Ingredient:	dutasteride
Patents:	0

Pharmacology for NDA: 021319

Mechanism of Action	5-alpha Reductase Inhibitors

Medical Subject Heading (MeSH) Categories for 021319

5-alpha Reductase Inhibitors

Suppliers and Packaging for NDA: 021319

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AVODART	dutasteride	CAPSULE;ORAL	021319	NDA	Waylis Therapeutics LLC	80725-712	80725-712-04	90 CAPSULE, LIQUID FILLED in 1 BOTTLE (80725-712-04)
AVODART	dutasteride	CAPSULE;ORAL	021319	NDA	Waylis Therapeutics LLC	80725-712	80725-712-15	30 CAPSULE, LIQUID FILLED in 1 BOTTLE (80725-712-15)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.5MG
Approval Date:	Nov 20, 2001	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021319

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Waylis Therap	AVODART	dutasteride	CAPSULE;ORAL	021319-001	Nov 20, 2001	5,565,467	⤷ Get Started Free
Waylis Therap	AVODART	dutasteride	CAPSULE;ORAL	021319-001	Nov 20, 2001	5,998,427	⤷ Get Started Free
Waylis Therap	AVODART	dutasteride	CAPSULE;ORAL	021319-001	Nov 20, 2001	5,846,976	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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