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Details for New Drug Application (NDA): 205109
NDA 205109 describes VELPHORO, which is a drug marketed by Vifor Fresenius and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the VELPHORO profile page.
The generic ingredient in VELPHORO is sucroferric oxyhydroxide. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sucroferric oxyhydroxide profile page.
The generic ingredient in VELPHORO is sucroferric oxyhydroxide. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sucroferric oxyhydroxide profile page.
Summary for 205109
| Tradename: | VELPHORO |
| Applicant: | Vifor Fresenius |
| Ingredient: | sucroferric oxyhydroxide |
| Patents: | 2 |
Suppliers and Packaging for NDA: 205109
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VELPHORO | sucroferric oxyhydroxide | TABLET, CHEWABLE;ORAL | 205109 | NDA | Fresenius Medical Care North America | 49230-645 | N | 49230-645-51 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 500MG | ||||
| Approval Date: | Nov 27, 2013 | TE: | RLD: | Yes | |||||
| Patent: | ➤ Sign Up | Patent Expiration: | Dec 19, 2018 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patented Use: | CONTROL OF PHOSPHOROUS LEVELS IN PATIENTS | ||||||||
| Patent: | ➤ Sign Up | Patent Expiration: | Jan 23, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | CONTROL OF PHOSPHOROUS LEVELS IN PATIENTS | ||||||||
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