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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 suppliers are listed for this compound. There are twelve tentative approvals for this compound. Additional details are available on the zoledronic acid profile page.

Summary for NDA: 021817

Tradename:
RECLAST
Applicant:
Novartis
Ingredient:
zoledronic acid
Patents:2
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021817

Ingredient-typeDiphosphonates

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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)StrengthEQ 5MG BASE/100ML
Approval Date:Apr 16, 2007TE:APRLD:Yes
Patent:7,932,241*PEDPatent Expiration:Aug 5, 2028Product Flag?Substance Flag?Delist Request?Y
Patent:8,052,987Patent 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 Orange Book Patents for NDA: 021817

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
RECLAST
zoledronic acid
INJECTABLE;IV (INFUSION)021817-001Apr 16, 20074,939,130*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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