Details for New Drug Application (NDA): 217319
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NDA 217319 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, Shandong Xinhua, Sinotherapeutics Inc, and Zydus Pharms, and is included in twenty-four NDAs. It is available from twenty-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. Twenty-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. Twenty-six suppliers are listed for this compound. Additional details are available on the sevelamer carbonate profile page.
Summary for 217319
| Tradename: | SEVELAMER CARBONATE |
| Applicant: | Chartwell Rx |
| Ingredient: | sevelamer carbonate |
| Patents: | 0 |
Pharmacology for NDA: 217319
| Mechanism of Action | Phosphate Chelating Activity |
Suppliers and Packaging for NDA: 217319
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SEVELAMER CARBONATE | sevelamer carbonate | FOR SUSPENSION;ORAL | 217319 | ANDA | Hangzhou Anprime Biopharm Co., Ltd. | 72823-301 | 72823-301-05 | 90 PACKAGE in 1 CARTON (72823-301-05) / 1 POWDER, FOR SUSPENSION in 1 PACKAGE (72823-301-01) |
| SEVELAMER CARBONATE | sevelamer carbonate | FOR SUSPENSION;ORAL | 217319 | ANDA | Hangzhou Anprime Biopharm Co., Ltd. | 72823-302 | 72823-302-05 | 90 PACKAGE in 1 CARTON (72823-302-05) / 1 POWDER, FOR SUSPENSION in 1 PACKAGE (72823-302-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 800MG/PACKET | ||||
| Approval Date: | Mar 2, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 2.4GM/PACKET | ||||
| Approval Date: | Mar 2, 2023 | TE: | AB | RLD: | No | ||||
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