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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050740

AMBISOME (AMPHOTERICIN B)
50MG/VIAL
Marketing Status: Prescription
Active Ingredient: AMPHOTERICIN B
Proprietary Name: AMBISOME
Dosage Form; Route of Administration: INJECTABLE, LIPOSOMAL; INJECTION
Strength: 50MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N050740
Product Number: 001
Approval Date: Aug 11, 1997
Applicant Holder Full Name: ASTELLAS PHARMA US INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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