Details for New Drug Application (NDA): 206100
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NDA 206100 describes SEVELAMER CARBONATE, which is a drug marketed by Aurobindo Pharma, Bionpharma, Chartwell Rx, Dr Reddys, Impax, Invagen Pharms, Lupin, Macleods Pharms Ltd, Strides Pharma Intl, Torrent, Amneal Pharms Co, Arthur Grp, Epic Pharma Llc, Impax Labs Inc, Micro Labs, Navinta Llc, Rising, Shandong Xinhua, Strides Pharma, and Zydus Pharms, and is included in twenty-six NDAs. It is available from thirty-four 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. Thirty-six 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. Thirty-six suppliers are listed for this compound. Additional details are available on the sevelamer carbonate profile page.
Summary for 206100
| Tradename: | SEVELAMER CARBONATE |
| Applicant: | Macleods Pharms Ltd |
| Ingredient: | sevelamer carbonate |
| Patents: | 0 |
Pharmacology for NDA: 206100
| Mechanism of Action | Phosphate Chelating Activity |
Suppliers and Packaging for NDA: 206100
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SEVELAMER CARBONATE | sevelamer carbonate | TABLET;ORAL | 206100 | ANDA | Macleods Pharmaceuticals Limited | 33342-215 | 33342-215-56 | 14 BLISTER PACK in 1 CARTON (33342-215-56) / 10 TABLET, FILM COATED in 1 BLISTER PACK |
| SEVELAMER CARBONATE | sevelamer carbonate | TABLET;ORAL | 206100 | ANDA | Macleods Pharmaceuticals Limited | 33342-215 | 33342-215-57 | 180 TABLET, FILM COATED in 1 BOTTLE (33342-215-57) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG | ||||
| Approval Date: | Apr 19, 2023 | TE: | AB | RLD: | No | ||||
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