Product Details for NDA 212306
XPOVIO (SELINEXOR)
20MG
Marketing Status: Prescription
40MG
Marketing Status: Prescription
50MG
Marketing Status: Prescription
60MG
Marketing Status: Prescription
20MG
Marketing Status: Prescription
Active Ingredient: SELINEXOR
Proprietary Name: XPOVIO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N212306
Product Number: 001
Approval Date: Jul 3, 2019
Applicant Holder Full Name: KARYOPHARM THERAPEUTICS INC
Marketing Status: Prescription
Patent and Exclusivity Information
XPOVIO (SELINEXOR)
Proprietary Name: XPOVIO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N212306
Product Number: 001
Approval Date: Jul 3, 2019
Applicant Holder Full Name: KARYOPHARM THERAPEUTICS INC
Marketing Status: Prescription
Patent and Exclusivity Information
40MG
Marketing Status: Prescription
Active Ingredient: SELINEXOR
Proprietary Name: XPOVIO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N212306
Product Number: 002
Approval Date: Apr 15, 2021
Applicant Holder Full Name: KARYOPHARM THERAPEUTICS INC
Marketing Status: Prescription
Patent and Exclusivity Information
XPOVIO (SELINEXOR)
Proprietary Name: XPOVIO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N212306
Product Number: 002
Approval Date: Apr 15, 2021
Applicant Holder Full Name: KARYOPHARM THERAPEUTICS INC
Marketing Status: Prescription
Patent and Exclusivity Information
50MG
Marketing Status: Prescription
Active Ingredient: SELINEXOR
Proprietary Name: XPOVIO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N212306
Product Number: 003
Approval Date: Apr 15, 2021
Applicant Holder Full Name: KARYOPHARM THERAPEUTICS INC
Marketing Status: Prescription
Patent and Exclusivity Information
XPOVIO (SELINEXOR)
Proprietary Name: XPOVIO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N212306
Product Number: 003
Approval Date: Apr 15, 2021
Applicant Holder Full Name: KARYOPHARM THERAPEUTICS INC
Marketing Status: Prescription
Patent and Exclusivity Information
60MG
Marketing Status: Prescription
Active Ingredient: SELINEXOR
Proprietary Name: XPOVIO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 60MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N212306
Product Number: 004
Approval Date: Apr 15, 2021
Applicant Holder Full Name: KARYOPHARM THERAPEUTICS INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: XPOVIO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 60MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N212306
Product Number: 004
Approval Date: Apr 15, 2021
Applicant Holder Full Name: KARYOPHARM THERAPEUTICS INC
Marketing Status: Prescription
Patent and Exclusivity Information