Product NDC: | 58468-0131 |
Proprietary Name: | Renvela |
Non Proprietary Name: | SEVELAMER CARBONATE |
Active Ingredient(s): | 2400 mg/1 & nbsp; SEVELAMER CARBONATE |
Administration Route(s): | ORAL |
Dosage Form(s): | POWDER, FOR SUSPENSION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 58468-0131 |
Labeler Name: | Genzyme Corporation |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA022318 |
Marketing Category: | NDA |
Start Marketing Date: | 20090812 |
Package NDC: | 58468-0131-5 |
Package Description: | 15 PACKET in 1 CARTON (58468-0131-5) > 1 POWDER, FOR SUSPENSION in 1 PACKET (58468-0131-3) |
NDC Code | 58468-0131-5 |
Proprietary Name | Renvela |
Package Description | 15 PACKET in 1 CARTON (58468-0131-5) > 1 POWDER, FOR SUSPENSION in 1 PACKET (58468-0131-3) |
Product NDC | 58468-0131 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | SEVELAMER CARBONATE |
Dosage Form Name | POWDER, FOR SUSPENSION |
Route Name | ORAL |
Start Marketing Date | 20090812 |
Marketing Category Name | NDA |
Labeler Name | Genzyme Corporation |
Substance Name | SEVELAMER CARBONATE |
Strength Number | 2400 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] |