FDA Approval Activities for this Drug…

Valcyte (valganciclovir HCl) Tablets, 450 mg, Hoffman-La Roche NDA 21-304/S1 9/12/03 9/25/03 9/25/03 Valcyte (valganciclovir HCl) Tablets, 450 mg, Roche Global Development-Palo NDA 21-304 3/29/01 4/13/01 4/13/01 Valcyte Indications: Treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS).

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