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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 065343

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EPIRUBICIN HYDROCHLORIDE (EPIRUBICIN HYDROCHLORIDE)
10MG/5ML (2MG/ML)
Marketing Status: Discontinued
Active Ingredient: EPIRUBICIN HYDROCHLORIDE
Proprietary Name: EPIRUBICIN HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10MG/5ML (2MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A065343
Product Number: 001
Approval Date: Apr 19, 2007
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
EPIRUBICIN HYDROCHLORIDE (EPIRUBICIN HYDROCHLORIDE)
50MG/25ML (2MG/ML)
Marketing Status: Discontinued
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: 
Application Number: A065343
Product Number: 002
Approval Date: Apr 19, 2007
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
EPIRUBICIN HYDROCHLORIDE (EPIRUBICIN HYDROCHLORIDE)
150MG/75ML (2MG/ML)
Marketing Status: Discontinued
Active Ingredient: EPIRUBICIN HYDROCHLORIDE
Proprietary Name: EPIRUBICIN HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 150MG/75ML (2MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A065343
Product Number: 003
Approval Date: Apr 19, 2007
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
EPIRUBICIN HYDROCHLORIDE (EPIRUBICIN HYDROCHLORIDE)
200MG/100ML (2MG/ML)
Marketing Status: Discontinued
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: 
Application Number: A065343
Product Number: 004
Approval Date: Apr 19, 2007
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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