Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 212306

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XPOVIO (SELINEXOR)
10MG
Marketing Status: Prescription

Active Ingredient: SELINEXOR
Proprietary Name: XPOVIO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212306
Product Number: 005
Approval Date: Mar 10, 2025
Applicant Holder Full Name: KARYOPHARM THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

XPOVIO (SELINEXOR)
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)
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)
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)
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

XPOVIO (SELINEXOR)
80MG
Marketing Status: Prescription

Active Ingredient: SELINEXOR
Proprietary Name: XPOVIO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 80MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212306
Product Number: 006
Approval Date: Oct 20, 2025
Applicant Holder Full Name: KARYOPHARM THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information