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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 207341

ZOLEDRONIC ACID (ZOLEDRONIC ACID)
EQ 4MG BASE/5ML
Marketing Status: Prescription
Active Ingredient: ZOLEDRONIC ACID
Proprietary Name: ZOLEDRONIC ACID
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: EQ 4MG BASE/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A207341
Product Number: 001
Approval Date: Dec 29, 2017
Applicant Holder Full Name: BPI LABS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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