FDA Approval Activities for this Drug…

Renagel Tablets, 400mg & 800mg, GelTex NDA 21-179 7/12/00 7/14/00 7/14/00 GelTex Indication: provides for a new dosage form of Renegel. Renagel (sevelamer hydrochloride) Capsules, GelTex NDA 20-926 10/30/98 11/2/98 11/2/98 7/4/99 GelTex Indication: for the reduction of serum phosphorus in patients with end stage renal disease who are on hemodialysis. Renagel (sevelamer hydrochloride) Capsules, GelTex NDA 20-926/S002 5/5/00 2/22/00 GelTex Indication: for the reduction of serum phosphorus in patients with end stage renal disease. SEVELAMER HYDROCHLORIDE Capsule; 403MG RENAGEL GENZYME 021179 SEVELAMER HYDROCHLORIDE Tablet; 400MG RENAGEL GENZYME 021179 SEVELAMER HYDROCHLORIDE Tablet; 800MG RENAGEL GENZYME Renagel (sevelamer hydrochloride) Capsules & Tablets, Genzyme Corporation

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