Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

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   For the latest approval information, locate this drug using this index.