Details for New Drug Application (NDA): 211316
✉ Email this page to a colleague
NDA 211316 describes SEVELAMER CARBONATE, which is a drug marketed by Aurobindo Pharma, Bionpharma, Chartwell Rx, Dr Reddys, Impax, Invagen Pharms, Lupin Ltd, Macleods Pharms Ltd, Strides Pharma, Amneal Pharms Co, Arthur Grp, Impax Labs Inc, Micro Labs, Rising, Sinotherapeutics Inc, and Zydus Pharms, and is included in twenty-three NDAs. It is available from twenty-five suppliers. Additional details are available on the SEVELAMER CARBONATE profile page.
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.
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 211316
| Tradename: | SEVELAMER CARBONATE |
| Applicant: | Impax |
| Ingredient: | sevelamer carbonate |
| Patents: | 0 |
Pharmacology for NDA: 211316
| Mechanism of Action | Phosphate Chelating Activity |
Suppliers and Packaging for NDA: 211316
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SEVELAMER CARBONATE | sevelamer carbonate | FOR SUSPENSION;ORAL | 211316 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-1365 | 0115-1365-29 | 90 PACKET in 1 CARTON (0115-1365-29) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0115-1365-30) |
| SEVELAMER CARBONATE | sevelamer carbonate | FOR SUSPENSION;ORAL | 211316 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-1366 | 0115-1366-29 | 90 PACKET in 1 CARTON (0115-1366-29) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0115-1366-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 800MG/PACKET | ||||
| Approval Date: | Nov 20, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 2.4GM/PACKET | ||||
| Approval Date: | Nov 20, 2020 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
