Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021361

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XIFAXAN (RIFAXIMIN)
200MG
Marketing Status: Prescription
Active Ingredient: RIFAXIMIN
Proprietary Name: XIFAXAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021361
Product Number: 001
Approval Date: May 25, 2004
Applicant Holder Full Name: SALIX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
XIFAXAN (RIFAXIMIN)
550MG
Marketing Status: Prescription
Active Ingredient: RIFAXIMIN
Proprietary Name: XIFAXAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 550MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021361
Product Number: 002
Approval Date: Mar 24, 2010
Applicant Holder Full Name: SALIX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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