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Details for New Drug Application (NDA): 205109

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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 is one patent 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.

Summary for NDA: 205109

Tradename:
VELPHORO
Applicant:
Vifor Fresenius
Ingredient:
sucroferric oxyhydroxide
Patents:1

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 49230-645-51 1 BOTTLE in 1 CARTON (49230-645-51) > 90 TABLET, CHEWABLE in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength500MG
Approval Date:Nov 27, 2013TE:RLD:Yes
Patent:6,174,442Patent Expiration:Dec 19, 2017Product Flag?Substance Flag?YDelist Request?
Patented Use:CONTROL OF PHOSPHOROUS LEVELS IN PATIENTS
Regulatory Exclusivity Expiration:Nov 27, 2016
Regulatory Exclusivity Use:NEW PRODUCT


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