SYMDEKO
These highlights do not include all the information needed to use SYMDEKO safely and effectively. See full prescribing information for SYMDEKO. SYMDEKO (tezacaftor/ivacaftor) tablets; (ivacaftor) tablets, for oral useInitial U.S. Approval: 2018
Approved
Approval ID
302ae804-37db-44fd-ac2f-3dbdeda9aa4b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 16, 2023
Manufacturers
FDA
Vertex Pharmaceuticals Incorporated
DUNS: 602478257
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tezacaftor and Ivacaftor
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51167-661
Application NumberNDA210491
Product Classification
M
Marketing Category
C73594
G
Generic Name
Tezacaftor and Ivacaftor
Product Specifications
Effective DateAugust 10, 2023
FDA Product Classification
Tezacaftor and Ivacaftor
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51167-113
Application NumberNDA210491
Product Classification
M
Marketing Category
C73594
G
Generic Name
Tezacaftor and Ivacaftor
Product Specifications
Effective DateAugust 10, 2023
FDA Product Classification