Details for New Drug Application (NDA): 207624
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NDA 207624 describes SEVELAMER CARBONATE, which is a drug marketed by Aurobindo Pharma, Bionpharma, Chartwell Rx, Dr Reddys, Impax, Lupin Ltd, Strides Pharma, Amneal Pharms Co, Anxin, Arthur Grp, Impax Labs Inc, Invagen Pharms, Macleods Pharms Ltd, Micro Labs, Rising, and Zydus Pharms, and is included in twenty 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 207624
| Tradename: | SEVELAMER CARBONATE |
| Applicant: | Aurobindo Pharma |
| Ingredient: | sevelamer carbonate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 207624
| Mechanism of Action | Phosphate Chelating Activity |
Suppliers and Packaging for NDA: 207624
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SEVELAMER CARBONATE | sevelamer carbonate | FOR SUSPENSION;ORAL | 207624 | ANDA | Aurobindo Pharma Limited | 65862-930 | 65862-930-90 | 90 POUCH in 1 CARTON (65862-930-90) / 1 POWDER, FOR SUSPENSION in 1 POUCH (65862-930-08) |
| SEVELAMER CARBONATE | sevelamer carbonate | FOR SUSPENSION;ORAL | 207624 | ANDA | Aurobindo Pharma Limited | 65862-931 | 65862-931-90 | 90 POUCH in 1 CARTON (65862-931-90) / 1 POWDER, FOR SUSPENSION in 1 POUCH (65862-931-08) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 800MG/PACKET | ||||
| Approval Date: | Jun 13, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 2.4GM/PACKET | ||||
| Approval Date: | Jun 13, 2017 | TE: | AB | RLD: | No | ||||
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