Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208462

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NINLARO (IXAZOMIB CITRATE)
EQ 2.3MG BASE
Marketing Status: Prescription

Active Ingredient: IXAZOMIB CITRATE
Proprietary Name: NINLARO
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 2.3MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208462
Product Number: 001
Approval Date: Nov 20, 2015
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

NINLARO (IXAZOMIB CITRATE)
EQ 3MG BASE
Marketing Status: Prescription

Active Ingredient: IXAZOMIB CITRATE
Proprietary Name: NINLARO
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 3MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208462
Product Number: 002
Approval Date: Nov 20, 2015
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

NINLARO (IXAZOMIB CITRATE)
EQ 4MG BASE
Marketing Status: Prescription

Active Ingredient: IXAZOMIB CITRATE
Proprietary Name: NINLARO
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 4MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208462
Product Number: 003
Approval Date: Nov 20, 2015
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information