Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 207228

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DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) (DOXORUBICIN HYDROCHLORIDE)
20MG/10ML (2MG/ML)
Marketing Status: Prescription

Active Ingredient: DOXORUBICIN HYDROCHLORIDE
Proprietary Name: DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
Dosage Form; Route of Administration: INJECTABLE, LIPOSOMAL; INJECTION
Strength: 20MG/10ML (2MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207228
Product Number: 001
Approval Date: Oct 12, 2021
Applicant Holder Full Name: AYANA PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) (DOXORUBICIN HYDROCHLORIDE)
50MG/25ML (2MG/ML)
Marketing Status: Prescription

Active Ingredient: DOXORUBICIN HYDROCHLORIDE
Proprietary Name: DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
Dosage Form; Route of Administration: INJECTABLE, LIPOSOMAL; INJECTION
Strength: 50MG/25ML (2MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207228
Product Number: 002
Approval Date: Oct 12, 2021
Applicant Holder Full Name: AYANA PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information