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Last Updated: May 6, 2021

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Details for New Drug Application (NDA): 021817

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NDA 021817 describes RECLAST, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the RECLAST profile page.

The generic ingredient in RECLAST is zoledronic acid. There are twenty-five drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.
Summary for 021817
Ingredient:zoledronic acid
Formulation / Manufacturing:see details
Pharmacology for NDA: 021817
Suppliers and Packaging for NDA: 021817
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RECLAST zoledronic acid INJECTABLE;INTRAVENOUS 021817 NDA Novartis Pharmaceuticals Corporation 0078-0435 0078-0435-61 100 mL in 1 BOTTLE (0078-0435-61)
Paragraph IV (Patent) Challenges for 021817
Tradename Dosage Ingredient NDA Submissiondate
RECLAST INJECTABLE;INTRAVENOUS zoledronic acid 021817 2008-08-29

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 5MG BASE/100ML
Approval Date:Apr 16, 2007TE:APRLD:Yes
Patent:  Get Started for $10Patent Expiration:Aug 5, 2028Product Flag?Substance Flag?Delist Request?Y
Patent:  Get Started for $10Patent Expiration:Oct 27, 2023Product Flag?Substance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson

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