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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 065289

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EPIRUBICIN HYDROCHLORIDE (EPIRUBICIN HYDROCHLORIDE)
50MG/25ML (2MG/ML)
Marketing Status: Prescription
Active Ingredient: EPIRUBICIN HYDROCHLORIDE
Proprietary Name: EPIRUBICIN HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 50MG/25ML (2MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A065289
Product Number: 001
Approval Date: Jun 27, 2007
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
EPIRUBICIN HYDROCHLORIDE (EPIRUBICIN HYDROCHLORIDE)
200MG/100ML (2MG/ML)
Marketing Status: Prescription
Active Ingredient: EPIRUBICIN HYDROCHLORIDE
Proprietary Name: EPIRUBICIN HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 200MG/100ML (2MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A065289
Product Number: 002
Approval Date: Jun 27, 2007
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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