FDA Approval Activities for this Drug
Alkeran (mephalan hydrochloride) Injection, SmithKlineBeecham NDA 20-207/S-007 4/29/03
Alkeran (mephalan) Tablets, SmithKlineBeecham NDA 14-691/S-024 5/14/03 7/9/03
Alkeran (mephalan) Tablets 2 mg, and Alkeran (mephalan hydrochloride) Injection, SmithKlineBeecham d/b/a GlaxoSmithKline NDA 14-691/S-023 & 20-207/S-005 1/7/02 2/8/02
ALKERAN (melphalan) Tablets Glaxo Wellcome, NDA 14-691/S-020 | Alkeran (melphalan) Tablets, GlaxoSmithKline, Labeling Revision | Alkeran (melphalan hydrochloride) for Injection, GlaxoSmithKline, Labeling Revision