sevelamer hydrochloride

FDA Drug Profile — sevelamer hydrochloride

sevelamer hydrochloride is listed in the FDA National Drug Code directory with 5 NDC codes, marketed under brand name including sevelamer hydrochloride. Available dosage form: tablet, film coated.

Drug Details

Generic Name
sevelamer hydrochloride
Brand Names
sevelamer hydrochloride
Application Number
ANDA204724
Sponsor
Major Pharmaceuticals
NDC Codes
5
Dosage Forms
TABLET, FILM COATED
Routes
PARENTERAL, ORAL
Active Ingredients
SEVELAMER HYDROCHLORIDE

Indications and Usage

1. INDICATIONS AND USAGE Sevelamer hydrochloride tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The safety and efficacy of sevelamer hydrochloride tablets in CKD patients who are not on dialysis have not been studied. Sevelamer hydrochloride tablets are a phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis. ( 1 )