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Last Updated: December 5, 2023

Details for New Drug Application (NDA): 021817

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NDA 021817 describes RECLAST, which is a drug marketed by Sandoz 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-five suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.

Summary for 021817

Tradename:	RECLAST
Applicant:	Sandoz
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;INTRAVENOUS	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:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 5MG BASE/100ML
Approval Date:	Apr 16, 2007	TE:	AP	RLD:	Yes
Patent:	⤷ Try a Trial	Patent Expiration:	Aug 5, 2028	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Try a Trial	Patent Expiration:	Oct 27, 2023	Product 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	RECLAST	zoledronic acid	INJECTABLE;INTRAVENOUS	021817-001	Apr 16, 2007	⤷ Try a Trial	⤷ Try a Trial
Sandoz	RECLAST	zoledronic acid	INJECTABLE;INTRAVENOUS	021817-001	Apr 16, 2007	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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