Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 213498

Expand all

PONVORY (PONESIMOD)
2MG
Marketing Status: Prescription

Active Ingredient: PONESIMOD
Proprietary Name: PONVORY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213498
Product Number: 001
Approval Date: Mar 18, 2021
Applicant Holder Full Name: VANDA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PONVORY (PONESIMOD)
3MG
Marketing Status: Prescription

Active Ingredient: PONESIMOD
Proprietary Name: PONVORY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 3MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213498
Product Number: 002
Approval Date: Mar 18, 2021
Applicant Holder Full Name: VANDA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PONVORY (PONESIMOD)
4MG
Marketing Status: Prescription

Active Ingredient: PONESIMOD
Proprietary Name: PONVORY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213498
Product Number: 003
Approval Date: Mar 18, 2021
Applicant Holder Full Name: VANDA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PONVORY (PONESIMOD)
5MG
Marketing Status: Prescription

Active Ingredient: PONESIMOD
Proprietary Name: PONVORY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213498
Product Number: 004
Approval Date: Mar 18, 2021
Applicant Holder Full Name: VANDA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PONVORY (PONESIMOD)
6MG
Marketing Status: Prescription

Active Ingredient: PONESIMOD
Proprietary Name: PONVORY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 6MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213498
Product Number: 005
Approval Date: Mar 18, 2021
Applicant Holder Full Name: VANDA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PONVORY (PONESIMOD)
7MG
Marketing Status: Prescription

Active Ingredient: PONESIMOD
Proprietary Name: PONVORY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 7MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213498
Product Number: 006
Approval Date: Mar 18, 2021
Applicant Holder Full Name: VANDA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PONVORY (PONESIMOD)
8MG
Marketing Status: Prescription

Active Ingredient: PONESIMOD
Proprietary Name: PONVORY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 8MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213498
Product Number: 007
Approval Date: Mar 18, 2021
Applicant Holder Full Name: VANDA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PONVORY (PONESIMOD)
9MG
Marketing Status: Prescription

Active Ingredient: PONESIMOD
Proprietary Name: PONVORY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 9MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213498
Product Number: 008
Approval Date: Mar 18, 2021
Applicant Holder Full Name: VANDA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PONVORY (PONESIMOD)
10MG
Marketing Status: Prescription

Active Ingredient: PONESIMOD
Proprietary Name: PONVORY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213498
Product Number: 009
Approval Date: Mar 18, 2021
Applicant Holder Full Name: VANDA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PONVORY (PONESIMOD)
20MG
Marketing Status: Prescription

Active Ingredient: PONESIMOD
Proprietary Name: PONVORY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213498
Product Number: 010
Approval Date: Mar 18, 2021
Applicant Holder Full Name: VANDA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information