Details for New Drug Application (NDA): 215537
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NDA 215537 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 215537
| Tradename: | SEVELAMER CARBONATE |
| Applicant: | Micro Labs |
| Ingredient: | sevelamer carbonate |
| Patents: | 0 |
Pharmacology for NDA: 215537
| Mechanism of Action | Phosphate Chelating Activity |
Suppliers and Packaging for NDA: 215537
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SEVELAMER CARBONATE | sevelamer carbonate | TABLET;ORAL | 215537 | ANDA | Micro Labs Limited | 42571-378 | 42571-378-30 | 30 TABLET in 1 BOTTLE (42571-378-30) |
| SEVELAMER CARBONATE | sevelamer carbonate | TABLET;ORAL | 215537 | ANDA | Micro Labs Limited | 42571-378 | 42571-378-43 | 270 TABLET in 1 BOTTLE (42571-378-43) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG | ||||
| Approval Date: | Feb 7, 2022 | TE: | AB | RLD: | No | ||||
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