Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 216951

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JESDUVROQ (DAPRODUSTAT)
1MG
Marketing Status: Prescription

Active Ingredient: DAPRODUSTAT
Proprietary Name: JESDUVROQ
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216951
Product Number: 001
Approval Date: Feb 1, 2023
Applicant Holder Full Name: GLAXOSMITHKLINE INTELLECTUAL PROPERTY NO 2 LTD ENGLAND
Marketing Status:  Prescription
Patent and Exclusivity Information

JESDUVROQ (DAPRODUSTAT)
2MG
Marketing Status: Prescription

Active Ingredient: DAPRODUSTAT
Proprietary Name: JESDUVROQ
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216951
Product Number: 002
Approval Date: Feb 1, 2023
Applicant Holder Full Name: GLAXOSMITHKLINE INTELLECTUAL PROPERTY NO 2 LTD ENGLAND
Marketing Status:  Prescription
Patent and Exclusivity Information

JESDUVROQ (DAPRODUSTAT)
4MG
Marketing Status: Prescription

Active Ingredient: DAPRODUSTAT
Proprietary Name: JESDUVROQ
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216951
Product Number: 003
Approval Date: Feb 1, 2023
Applicant Holder Full Name: GLAXOSMITHKLINE INTELLECTUAL PROPERTY NO 2 LTD ENGLAND
Marketing Status:  Prescription
Patent and Exclusivity Information

JESDUVROQ (DAPRODUSTAT)
6MG
Marketing Status: Prescription

Active Ingredient: DAPRODUSTAT
Proprietary Name: JESDUVROQ
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 6MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216951
Product Number: 004
Approval Date: Feb 1, 2023
Applicant Holder Full Name: GLAXOSMITHKLINE INTELLECTUAL PROPERTY NO 2 LTD ENGLAND
Marketing Status:  Prescription
Patent and Exclusivity Information

JESDUVROQ (DAPRODUSTAT)
8MG
Marketing Status: Prescription

Active Ingredient: DAPRODUSTAT
Proprietary Name: JESDUVROQ
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 8MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216951
Product Number: 005
Approval Date: Feb 1, 2023
Applicant Holder Full Name: GLAXOSMITHKLINE INTELLECTUAL PROPERTY NO 2 LTD ENGLAND
Marketing Status:  Prescription
Patent and Exclusivity Information