Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com