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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 | Novantrone (mitoxantrone concentrate) injection, Serono, Labeling Revision | Mitoxantrone HCI Injection, American Pharma Partners, Approval | Mitoxantrone Injection, Mayne Pharma, Approval | Mitoxantrone Hydrochloride Injection, Sicor Pharma, Approval | Mitoxantrone Injection, Bedford Labs, Approval | Novantrone (mitoxantrone) Injection, EMD Serono Inc., Manufacturing Change or Addition | Mitoxantrone Hydrochloride Injection, Dabur Oncology, Plc., Approval | Novantrone (mitoxantrone hydrochloride) Injection, EMD Serono, Inc., Labeling Revision | Mitoxantrone Hydrochloride Injection, GeneraMedix, Inc., Approval | Novantrone (mitoxantrone hydrochloride) Injection, EMD Serono, Labeling Revision
  
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