Product Details for NDA 208462
NINLARO (IXAZOMIB CITRATE)
EQ 2.3MG BASE
Marketing Status: Prescription
EQ 3MG BASE
Marketing Status: Prescription
EQ 4MG BASE
Marketing Status: Prescription
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)
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
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)
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
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
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