Application Nr Approved Date Route Status External Links
ANDA207179 2017-07-17 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Sevelamer Carbonate Tablets Are Indicated For The Control Of Serum Phosphorus In Adults With Chronic Kidney Disease (ckd) On Dialysis. Pediatric Use Information Is Approved For Genzyme Corporation’s Renvela (sevelamer Carbonate) Tablets And Renvela (sevelamer Carbonate) For Oral Suspension. However, Due To Genzyme Corporation’s Marketing Exclusivity Rights, These Drug Products Are Not Labeled With That Pediatric Information. Sevelamer Carbonate Tablets Are A Phosphate Binder Indicated For The Control Of Serum Phosphorus In Adults With Chronic Kidney Disease On Dialysis. (1)

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Ammonia AMMONIA Molecular
2. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
3. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
4. Glyceryl Dibehenate GLYCERYL DIBEHENATE Unresolved
5. Hypromelloses HYPROMELLOSES Unresolved
6. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.
7. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Sevelamer Carbonate SEVELAMER CARBONATE ZINC2016052

Comments