Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022065

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IXEMPRA KIT (IXABEPILONE)
15MG/VIAL
Marketing Status: Prescription

Active Ingredient: IXABEPILONE
Proprietary Name: IXEMPRA KIT
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 15MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022065
Product Number: 001
Approval Date: Oct 16, 2007
Applicant Holder Full Name: R-PHARM US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

IXEMPRA KIT (IXABEPILONE)
45MG/VIAL
Marketing Status: Prescription

Active Ingredient: IXABEPILONE
Proprietary Name: IXEMPRA KIT
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 45MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022065
Product Number: 002
Approval Date: Oct 16, 2007
Applicant Holder Full Name: R-PHARM US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information