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Last Updated: June 4, 2023

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-one 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:DISCNDosage:INJECTABLE;INTRAVENOUSStrengthEQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Aug 20, 2001TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 4MG BASE/5ML
Approval Date:Mar 7, 2003TE:APRLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Nov 29, 2025Product Flag?Substance Flag?Delist Request?Y

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 4MG BASE/100ML
Approval Date:Jun 17, 2011TE:APRLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Feb 5, 2028Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021223

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 021223-001 Aug 20, 2001 ⤷  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 021223-001 Aug 20, 2001 ⤷  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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