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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 205574

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BENDAMUSTINE HYDROCHLORIDE (BENDAMUSTINE HYDROCHLORIDE)
25MG/VIAL
Marketing Status: Prescription
Active Ingredient: BENDAMUSTINE HYDROCHLORIDE
Proprietary Name: BENDAMUSTINE HYDROCHLORIDE
Dosage Form; Route of Administration: POWDER; IV (INFUSION)
Strength: 25MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A205574
Product Number: 001
Approval Date: Dec 7, 2022
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
BENDAMUSTINE HYDROCHLORIDE (BENDAMUSTINE HYDROCHLORIDE)
100MG/VIAL
Marketing Status: Prescription
Active Ingredient: BENDAMUSTINE HYDROCHLORIDE
Proprietary Name: BENDAMUSTINE HYDROCHLORIDE
Dosage Form; Route of Administration: POWDER; IV (INFUSION)
Strength: 100MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A205574
Product Number: 002
Approval Date: Dec 7, 2022
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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