Augtyro
These highlights do not include all the information needed to use AUGTYRO safely and effectively. See full prescribing information for AUGTYRO.AUGTYRO (repotrectinib) capsules, for oral useInitial U.S. Approval: 2023
Approved
Approval ID
fb526827-40ba-4462-94cf-179ae3b0cb8a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 15, 2023
Manufacturers
FDA
E.R. Squibb & Sons, L.L.C.
DUNS: 011550092
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
repotrectinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0003-4040
Application NumberNDA218213
Product Classification
M
Marketing Category
C73594
G
Generic Name
repotrectinib
Product Specifications
Route of AdministrationORAL
Effective DateNovember 15, 2023
FDA Product Classification
INGREDIENTS (5)
REPOTRECTINIBActive
Quantity: 40 mg in 1 1
Code: 08O3FQ4UNP
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT