Details for New Drug Application (NDA): 207288
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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 207288
Tradename: | SEVELAMER CARBONATE |
Applicant: | Amneal Pharms Co |
Ingredient: | sevelamer carbonate |
Patents: | 0 |
Pharmacology for NDA: 207288
Mechanism of Action | Phosphate Chelating Activity |
Suppliers and Packaging for NDA: 207288
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SEVELAMER CARBONATE | sevelamer carbonate | TABLET;ORAL | 207288 | ANDA | AvPAK | 50268-720 | 50268-720-15 | 50 BLISTER PACK in 1 BOX (50268-720-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-720-11) |
SEVELAMER CARBONATE | sevelamer carbonate | TABLET;ORAL | 207288 | ANDA | Amneal Pharmaceuticals LLC | 65162-058 | 65162-058-03 | 30 TABLET, FILM COATED in 1 BOTTLE (65162-058-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG | ||||
Approval Date: | Nov 28, 2017 | TE: | AB | RLD: | No |
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