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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

Vifor Fresenius
sucroferric oxyhydroxide

Suppliers and Packaging for NDA: 205109

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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?
Regulatory Exclusivity Expiration:Nov 27, 2016
Regulatory Exclusivity Use:NEW PRODUCT

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.