Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com