Details for New Drug Application (NDA): 212599
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NDA 212599 describes SEVELAMER HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Lupin Ltd, Macleods Pharms Ltd, and Rising, and is included in five NDAs. It is available from seven suppliers. Additional details are available on the SEVELAMER HYDROCHLORIDE profile page.
The generic ingredient in SEVELAMER HYDROCHLORIDE is sevelamer hydrochloride. There are thirty-two drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the sevelamer hydrochloride profile page.
The generic ingredient in SEVELAMER HYDROCHLORIDE is sevelamer hydrochloride. There are thirty-two drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the sevelamer hydrochloride profile page.
Summary for 212599
| Tradename: | SEVELAMER HYDROCHLORIDE |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | sevelamer hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 212599
| Mechanism of Action | Phosphate Chelating Activity |
Suppliers and Packaging for NDA: 212599
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SEVELAMER HYDROCHLORIDE | sevelamer hydrochloride | TABLET;ORAL | 212599 | ANDA | Aurobindo Pharma Limited | 59651-087 | 59651-087-36 | 360 TABLET, FILM COATED in 1 BOTTLE (59651-087-36) |
| SEVELAMER HYDROCHLORIDE | sevelamer hydrochloride | TABLET;ORAL | 212599 | ANDA | Aurobindo Pharma Limited | 59651-088 | 59651-088-18 | 180 TABLET, FILM COATED in 1 BOTTLE (59651-088-18) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
| Approval Date: | Jul 11, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG | ||||
| Approval Date: | Jul 11, 2023 | TE: | AB | RLD: | No | ||||
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