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Details for New Drug Application (NDA): 022554

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NDA 022554 describes XIFAXAN, which is a drug marketed by Salix Pharms and is included in two NDAs. It is available from five suppliers. There are twenty-five 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. Five suppliers are listed for this compound. Additional details are available on the rifaximin profile page.

Summary for NDA: 022554

Salix Pharms
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 022554


Suppliers and Packaging for NDA: 022554

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 022554 NDA Physicians Total Care, Inc. 54868-6154 54868-6154-0 2 TABLET in 1 BOTTLE (54868-6154-0)
TABLET;ORAL 022554 NDA Physicians Total Care, Inc. 54868-6154 54868-6154-1 9 TABLET in 1 BOTTLE (54868-6154-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength550MG
Approval Date:Mar 24, 2010TE:RLD:Yes
Patent:7,045,620Patent Expiration:Jun 19, 2024Product Flag?Substance 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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