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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 021088

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NDA 021088 describes VIADUR, which is a drug marketed by Ortho Mcneil Janssen and is included in one NDA. Additional details are available on the VIADUR profile page.

The generic ingredient in VIADUR is leuprolide acetate. There are twenty-two drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.

Summary for 021088

Tradename:	VIADUR
Applicant:	Ortho Mcneil Janssen
Ingredient:	leuprolide acetate
Patents:	0

Medical Subject Heading (MeSH) Categories for 021088

Antineoplastic Agents, Hormonal
Fertility Agents, Female

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	IMPLANT;IMPLANTATION			Strength	EQ 65MG BASE
Approval Date:	Mar 3, 2000	TE:		RLD:	No

Expired US Patents for NDA 021088

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ortho Mcneil Janssen	VIADUR	leuprolide acetate	IMPLANT;IMPLANTATION	021088-001	Mar 3, 2000	5,728,396	⤷ Start Trial
Ortho Mcneil Janssen	VIADUR	leuprolide acetate	IMPLANT;IMPLANTATION	021088-001	Mar 3, 2000	6,395,292	⤷ Start Trial
Ortho Mcneil Janssen	VIADUR	leuprolide acetate	IMPLANT;IMPLANTATION	021088-001	Mar 3, 2000	6,132,420	⤷ Start Trial
Ortho Mcneil Janssen	VIADUR	leuprolide acetate	IMPLANT;IMPLANTATION	021088-001	Mar 3, 2000	6,375,978	⤷ Start Trial
Ortho Mcneil Janssen	VIADUR	leuprolide acetate	IMPLANT;IMPLANTATION	021088-001	Mar 3, 2000	6,235,712	⤷ Start Trial
Ortho Mcneil Janssen	VIADUR	leuprolide acetate	IMPLANT;IMPLANTATION	021088-001	Mar 3, 2000	5,932,547	⤷ Start Trial
Ortho Mcneil Janssen	VIADUR	leuprolide acetate	IMPLANT;IMPLANTATION	021088-001	Mar 3, 2000	6,124,261	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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