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SEVELAMER

 
 

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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 | Renagel (sevelamer hydrochloride) mg Tablets, Genzyme Corp., Labeling Revision | Renagel (sevelamer hydrochloride) Tablets, Genzyme Corp., Labeling Revision | Renagel (sevelamer hydrochloride) Tablets, Genzyme Corp., Efficacy Supp. w/Clinical Data | Renvela (sevelamer carbonate) Tablets, Genzyme Corp., Approval | Renvela (sevelamer carbonate) Oral Powder, Genzyme Corp., Approval | Renvela (sevelamer carbonate) Oral Suspension, Genzyme Corp., Approval | Renagel (sevelamer hydrochloride) Tablets, Genzyme Corporation, Labeling Revision | Renvela (sevelamer carbonate) Oral Suspension, Genzyme Corporation, Labeling Revision | Renvela (sevelamer carbonate) Tablets, Genzyme Corporation, Labeling Revision

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