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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 204040

AMIKACIN SULFATE (AMIKACIN SULFATE)
EQ 250MG BASE/ML
Marketing Status: Prescription
Active Ingredient: AMIKACIN SULFATE
Proprietary Name: AMIKACIN SULFATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 250MG BASE/ML
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A204040
Product Number: 001
Approval Date: Dec 12, 2013
Applicant Holder Full Name: AVET LIFESCIENCES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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