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TRUSELTIQ

These highlights do not include all the information needed to use TRUSELTIQ safely and effectively. See full prescribing information for TRUSELTIQ. TRUSELTIQ (infigratinib) capsules, for oral use Initial U.S. Approval: 2021

Approved
Approval ID

af9a96cf-1cd7-8ace-e053-2a95a90a18cc

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 7, 2022

Manufacturers
FDA

QED Therapeutics, Inc.

DUNS: 081223065

Products 4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

infigratinib

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72730-506
Application NumberNDA214622
Product Classification
M
Marketing Category
C73594
G
Generic Name
infigratinib
Product Specifications
Route of AdministrationORAL
Effective DateJune 3, 2021
FDA Product Classification

INGREDIENTS (1)

INFIGRATINIBActive
Quantity: 50 mg in 1 1
Code: A4055ME1VK
Classification: ACTIM

infigratinib

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72730-101
Application NumberNDA214622
Product Classification
M
Marketing Category
C73594
G
Generic Name
infigratinib
Product Specifications
Route of AdministrationORAL
Effective DateJune 3, 2021
FDA Product Classification

INGREDIENTS (1)

INFIGRATINIBActive
Quantity: 125 mg in 1 1
Code: A4055ME1VK
Classification: ACTIM

infigratinib

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72730-202
Application NumberNDA214622
Product Classification
M
Marketing Category
C73594
G
Generic Name
infigratinib
Product Specifications
Route of AdministrationORAL
Effective DateJune 3, 2021
FDA Product Classification

INGREDIENTS (1)

INFIGRATINIBActive
Quantity: 75 mg in 1 1
Code: A4055ME1VK
Classification: ACTIM

infigratinib

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72730-111
Application NumberNDA214622
Product Classification
M
Marketing Category
C73594
G
Generic Name
infigratinib
Product Specifications
Route of AdministrationORAL
Effective DateJune 3, 2021
FDA Product Classification

INGREDIENTS (1)

INFIGRATINIBActive
Quantity: 100 mg in 1 1
Code: A4055ME1VK
Classification: ACTIM

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TRUSELTIQ - FDA Drug Approval Details