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MELPHALAN

 
 

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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 | Melphalan Hydrochloride Injection, Synerx Pharma, LLC, Approval | Melphalan Hydrochloride Injection, GeneraMedix, Inc., Approval | Melphalan Hydrochloride Injection, Bedford Laboratories, Approval | Alkeran (melphalan hydrochloride) Injection, GlaxcoSmithKline, Labeling Revision | Alkeran (melphalan) Tablets, GlaxcoSmithKline, Labeling Revision | Alkeran (melphalan hydrochloride) Injection, GlaxcoSmithKline, Labeling Revision | Alkeran (melphalan) Tablets, GlaxcoSmithKline, Labeling Revision

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