Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022249

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TREANDA (BENDAMUSTINE HYDROCHLORIDE)
25MG/VIAL Marketing Status: Prescription

Active Ingredient: BENDAMUSTINE HYDROCHLORIDE
Proprietary Name: TREANDA
Dosage Form; Route of Administration: POWDER; IV (INFUSION)
Strength: 25MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N022249
Product Number: 002
Approval Date: May 1, 2009
Applicant Holder Full Name: CEPHALON INC
Marketing Status:  Prescription
Patent and Exclusivity Information

TREANDA (BENDAMUSTINE HYDROCHLORIDE)
100MG/VIAL Marketing Status: Prescription

Active Ingredient: BENDAMUSTINE HYDROCHLORIDE
Proprietary Name: TREANDA
Dosage Form; Route of Administration: POWDER; IV (INFUSION)
Strength: 100MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N022249
Product Number: 001
Approval Date: Mar 20, 2008
Applicant Holder Full Name: CEPHALON INC
Marketing Status:  Prescription
Patent and Exclusivity Information

TREANDA (BENDAMUSTINE HYDROCHLORIDE)
45MG/0.5ML (90MG/ML) Marketing Status: Discontinued

Active Ingredient: BENDAMUSTINE HYDROCHLORIDE
Proprietary Name: TREANDA
Dosage Form; Route of Administration: SOLUTION; IV (INFUSION)
Strength: 45MG/0.5ML (90MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022249
Product Number: 003
Approval Date: Sep 13, 2013
Applicant Holder Full Name: CEPHALON INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

TREANDA (BENDAMUSTINE HYDROCHLORIDE)
180MG/2ML (90MG/ML) Marketing Status: Discontinued

Active Ingredient: BENDAMUSTINE HYDROCHLORIDE
Proprietary Name: TREANDA
Dosage Form; Route of Administration: SOLUTION; IV (INFUSION)
Strength: 180MG/2ML (90MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022249
Product Number: 004
Approval Date: Sep 13, 2013
Applicant Holder Full Name: CEPHALON INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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