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Generated: May 22, 2017

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Details for New Drug Application (NDA): 021361

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NDA 021361 describes XIFAXAN, which is a drug marketed by Salix Pharms and is included in two NDAs. It is available from seven suppliers. There are twenty-six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the XIFAXAN profile page.

The generic ingredient in XIFAXAN is rifaximin. There are eleven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the rifaximin profile page.

Summary for NDA: 021361

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 021361


Suppliers and Packaging for NDA: 021361

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 021361 NDA A-S Medication Solutions 50090-2445 50090-2445-0 9 TABLET in 1 BOTTLE (50090-2445-0)
TABLET;ORAL 021361 NDA Physicians Total Care, Inc. 54868-5972 54868-5972-0 30 TABLET in 1 BOTTLE (54868-5972-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:May 25, 2004TE:RLD:Yes
Patent:7,045,620Patent Expiration:Jun 19, 2024Product Flag?YSubstance Flag?YDelist Request?
Patent:7,612,199Patent Expiration:Jun 19, 2024Product Flag?YSubstance Flag?YDelist Request?
Patent:7,902,206Patent Expiration:Jun 19, 2024Product Flag?YSubstance Flag?YDelist Request?

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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.

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