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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021817

RECLAST (ZOLEDRONIC ACID)
EQ 5MG BASE/100ML
Marketing Status: Prescription
Active Ingredient: ZOLEDRONIC ACID
Proprietary Name: RECLAST
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: EQ 5MG BASE/100ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N021817
Product Number: 001
Approval Date: Apr 16, 2007
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
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