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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020207

ALKERAN (MELPHALAN HYDROCHLORIDE)
EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: MELPHALAN HYDROCHLORIDE
Proprietary Name: ALKERAN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020207
Product Number: 001
Approval Date: Nov 18, 1992
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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