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Generated: January 22, 2019

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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-seven suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.
Summary for 021817
Tradename:RECLAST
Applicant:Novartis
Ingredient:zoledronic acid
Patents:2
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;IV (INFUSION) 021817 NDA Novartis Pharmaceuticals Corporation 0078-0435 0078-0435-61 100 mL in 1 BOTTLE (0078-0435-61)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)StrengthEQ 5MG BASE/100ML
Approval Date:Apr 16, 2007TE:APRLD:Yes
Patent:➤ Sign UpPatent Expiration:Aug 5, 2028Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Sign UpPatent Expiration:Oct 27, 2023Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT AND PREVENTION OF POSTMENOPAUSAL OR GLUCOCORTICOID-INDUCED OSTEOPOROSIS AND TREATMENT TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS

Expired US Patents for NDA 021817

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis RECLAST zoledronic acid INJECTABLE;IV (INFUSION) 021817-001 Apr 16, 2007 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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