Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

FDA Approval Activities for this Drug… Novantrone (mitoxantrone for Injection Concentrate), Serono, NDA 19-297/S25, S26 & S27 1/13/03 1/23/03 Novantrone (mitoxantrone for Injection Concentrate), Immunex NDA 19-297/S-024 2/20/02 2/21/02 Novantrone (mitoxantrone for Injection Concentrate), Immunex NDA 19-297/S-021 2/04/00 6/4/01 Novantrone (mitoxantrone hydrochloride) Injection,Rx Immunex NDA 21-120 10/13/00 Novantrone Indications: reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis. Mitoxantrone Injection, Bedford Laboratories, Mitoxantrone Injection, Mayne Pharma,   For the latest approval information, locate this drug using this index.