Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Helsinn Healthcare SA
481466936
Products4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TRUSELTIQ
Product Details
NDC Product Code
72730-506Application Number
NDA214622Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
June 3, 2021InfigratinibActive
Code: A4055ME1VKClass: ACTIMQuantity: 50 mg in 1 1
TRUSELTIQ
Product Details
NDC Product Code
72730-101Application Number
NDA214622Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
June 3, 2021InfigratinibActive
Code: A4055ME1VKClass: ACTIMQuantity: 125 mg in 1 1
TRUSELTIQ
Product Details
NDC Product Code
72730-202Application Number
NDA214622Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
June 3, 2021InfigratinibActive
Code: A4055ME1VKClass: ACTIMQuantity: 75 mg in 1 1
TRUSELTIQ
Product Details
NDC Product Code
72730-111Application Number
NDA214622Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
June 3, 2021InfigratinibActive
Code: A4055ME1VKClass: ACTIMQuantity: 100 mg in 1 1