FDA Approval Activities for this Drug…

Mesna Injection, 100 mg/mL (packaged in 10 mL multiple-dose vials), American Pharmaceutical Partners, ANDA 75-811 4/26/01 6/5/01 12/14/01 Mesna Injection, 100 mg/mL (packaged in 10 mL multiple-dose vials), Gensia Sicor ANDA 75-764 4/27/01 6/5/01 Mesnex (mesna) Injection & Tablets, Baxter Healthcare NDA 19-884/S007, S008 & 20-855 1/30/03 2/12/03 5/8/03 Mesnex (mesna) Tablets, 400 mg, Bristol-Myers Squibb NDA 20-855 IFOSFAMIDE; MESNA Injection 100MG/ML IFEX/MESNEX KIT BRISTOL MYERS SQUIBB 019763 IFOSFAMIDE; MESNA Injection 100MG/ML IFEX/MESNEX KIT BRISTOL MYERS SQUIBB 075874 IFOSFAMIDE; MESNA Intravenous 1GM /20ML(50MG/ML);1GM /10ML(100MG/ML) IFOSFAMIDE/MESNA KIT Gensia Sicor 075874 IFOSFAMIDE; MESNA Intravenous 3GM /60ML(50MG/ML);1GM /10ML(100MG/ML) IFOSFAMIDE/MESNA KIT Gensia Sicor 075811 MESNA Intravenous 100MG/ML MESNA AM PARTNERS 019884 MESNA Intravenous 100MG/ML MESNEX Baxter 075764 MESNA Intravenous 100MG/ML MESNA Gensia Sicor 020855 MESNA Tablet; 400MG MESNEX Baxter Mesna Injection, Bioniche Pharm,

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