Details for New Drug Application (NDA): 204451
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The generic ingredient in SEVELAMER CARBONATE is sevelamer carbonate. There are thirty-two drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the sevelamer carbonate profile page.
Summary for 204451
Tradename: | SEVELAMER CARBONATE |
Applicant: | Rising |
Ingredient: | sevelamer carbonate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204451
Mechanism of Action | Phosphate Chelating Activity |
Suppliers and Packaging for NDA: 204451
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SEVELAMER CARBONATE | sevelamer carbonate | TABLET;ORAL | 204451 | ANDA | Rising Pharmaceuticals, Inc. | 16571-739 | 16571-739-03 | 30 TABLET, FILM COATED in 1 BOTTLE (16571-739-03) |
SEVELAMER CARBONATE | sevelamer carbonate | TABLET;ORAL | 204451 | ANDA | Rising Pharmaceuticals, Inc. | 16571-739 | 16571-739-27 | 270 TABLET, FILM COATED in 1 BOTTLE (16571-739-27) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG | ||||
Approval Date: | Nov 29, 2018 | TE: | AB | RLD: | No |
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