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Last Updated: April 16, 2024

Details for New Drug Application (NDA): 021223

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NDA 021223 describes ZOMETA, which is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the ZOMETA profile page.

The generic ingredient in ZOMETA is zoledronic acid. There are twenty-five drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.

Summary for 021223

Tradename:	ZOMETA
Applicant:	Novartis
Ingredient:	zoledronic acid
Patents:	2
Formulation / Manufacturing:	see details

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 4MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Aug 20, 2001	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 4MG BASE/5ML
Approval Date:	Mar 7, 2003	TE:		RLD:	Yes
Patent:	⤷ Try a Trial	Patent Expiration:	Nov 29, 2025	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 4MG BASE/100ML
Approval Date:	Jun 17, 2011	TE:		RLD:	Yes
Patent:	⤷ Try a Trial	Patent Expiration:	Feb 5, 2028	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 021223

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	ZOMETA	zoledronic acid	INJECTABLE;INTRAVENOUS	021223-002	Mar 7, 2003	⤷ Try a Trial	⤷ Try a Trial
Novartis	ZOMETA	zoledronic acid	INJECTABLE;INTRAVENOUS	021223-002	Mar 7, 2003	⤷ Try a Trial	⤷ Try a Trial
Novartis	ZOMETA	zoledronic acid	INJECTABLE;INTRAVENOUS	021223-003	Jun 17, 2011	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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