FYARRO
These highlights do not include all the information needed to use FYARRO safely and effectively. See full prescribing information for FYARRO. FYARRO (sirolimus protein-bound particles for injectable suspension) (albumin-bound), for intravenous useInitial U.S. Approval: 2021
Approved
Approval ID
0f9bb784-53e2-46f9-a65d-1c6c2a230eaf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 6, 2021
Manufacturers
FDA
Aadi Bioscience
DUNS: 080934167
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sirolimus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code80803-153
Application NumberNDA213312
Product Classification
M
Marketing Category
C73594
G
Generic Name
Sirolimus
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 6, 2021
FDA Product Classification
INGREDIENTS (2)
ALBUMIN HUMANInactive
Code: ZIF514RVZR
Classification: IACT
SIROLIMUSActive
Quantity: 5 mg in 1 mL
Code: W36ZG6FT64
Classification: ACTIB