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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050718

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DOXIL (LIPOSOMAL) (DOXORUBICIN HYDROCHLORIDE)
20MG/10ML (2MG/ML)
Marketing Status: Prescription
Active Ingredient: DOXORUBICIN HYDROCHLORIDE
Proprietary Name: DOXIL (LIPOSOMAL)
Dosage Form; Route of Administration: INJECTABLE, LIPOSOMAL; INJECTION
Strength: 20MG/10ML (2MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N050718
Product Number: 001
Approval Date: Nov 17, 1995
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
DOXIL (LIPOSOMAL) (DOXORUBICIN HYDROCHLORIDE)
50MG/25ML (2MG/ML)
Marketing Status: Prescription
Active Ingredient: DOXORUBICIN HYDROCHLORIDE
Proprietary Name: DOXIL (LIPOSOMAL)
Dosage Form; Route of Administration: INJECTABLE, LIPOSOMAL; INJECTION
Strength: 50MG/25ML (2MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N050718
Product Number: 002
Approval Date: Jun 13, 2000
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
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