Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 211530

Expand all

BENDAMUSTINE HYDROCHLORIDE (BENDAMUSTINE HYDROCHLORIDE)
25MG/ML (25MG/ML)
Marketing Status: Discontinued

Active Ingredient: BENDAMUSTINE HYDROCHLORIDE
Proprietary Name: BENDAMUSTINE HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 25MG/ML (25MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211530
Product Number: 001
Approval Date: Dec 15, 2022
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

BENDAMUSTINE HYDROCHLORIDE (BENDAMUSTINE HYDROCHLORIDE)
100MG/4ML (25MG/ML)
Marketing Status: Discontinued

Active Ingredient: BENDAMUSTINE HYDROCHLORIDE
Proprietary Name: BENDAMUSTINE HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 100MG/4ML (25MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211530
Product Number: 002
Approval Date: Dec 15, 2022
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

BENDAMUSTINE HYDROCHLORIDE (BENDAMUSTINE HYDROCHLORIDE)
200MG/8ML (25MG/ML)
Marketing Status: Discontinued

Active Ingredient: BENDAMUSTINE HYDROCHLORIDE
Proprietary Name: BENDAMUSTINE HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 200MG/8ML (25MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211530
Product Number: 003
Approval Date: Dec 15, 2022
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information