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Details for New Drug Application (NDA): 205739
NDA 205739 describes VELTASSA, which is a drug marketed by Relypsa Inc and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the VELTASSA profile page.
The generic ingredient in VELTASSA is patiromer sorbitex calcium. One supplier is listed for this compound. Additional details are available on the patiromer sorbitex calcium profile page.
The generic ingredient in VELTASSA is patiromer sorbitex calcium. One supplier is listed for this compound. Additional details are available on the patiromer sorbitex calcium profile page.
Summary for 205739
| Tradename: | VELTASSA |
| Applicant: | Relypsa Inc |
| Ingredient: | patiromer sorbitex calcium |
| Patents: | 10 |
Pharmacology for NDA: 205739
| Mechanism of Action | Potassium Ion Binding Activity |
Suppliers and Packaging for NDA: 205739
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VELTASSA | patiromer sorbitex calcium | POWDER;ORAL | 205739 | NDA | Relypsa, Inc. | 53436-084 | N | 53436-084-04 |
| VELTASSA | patiromer sorbitex calcium | POWDER;ORAL | 205739 | NDA | Relypsa, Inc. | 53436-084 | N | 53436-084-30 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;ORAL | Strength | EQ 8.4GM BASE/PACKET | ||||
| Approval Date: | Oct 21, 2015 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 21, 2020 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ➤ Sign Up | Patent Expiration: | Feb 27, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF HYPERKALEMIA | ||||||||
| Patent: | ➤ Sign Up | Patent Expiration: | Mar 11, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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