Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 216665

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VYKAT XR (DIAZOXIDE CHOLINE)
25MG
Marketing Status: Prescription

Active Ingredient: DIAZOXIDE CHOLINE
Proprietary Name: VYKAT XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216665
Product Number: 001
Approval Date: Mar 26, 2025
Applicant Holder Full Name: SOLENO THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

VYKAT XR (DIAZOXIDE CHOLINE)
75MG
Marketing Status: Prescription

Active Ingredient: DIAZOXIDE CHOLINE
Proprietary Name: VYKAT XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 75MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216665
Product Number: 002
Approval Date: Mar 26, 2025
Applicant Holder Full Name: SOLENO THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

VYKAT XR (DIAZOXIDE CHOLINE)
150MG
Marketing Status: Prescription

Active Ingredient: DIAZOXIDE CHOLINE
Proprietary Name: VYKAT XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 150MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216665
Product Number: 003
Approval Date: Mar 26, 2025
Applicant Holder Full Name: SOLENO THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information