Temsirolimus
These highlights do not include all the information needed to use TEMSIROLIMUS INJECTION safely and effectively. See full prescribing information for TEMSIROLIMUS INJECTION. TEMSIROLIMUS injection, for intravenous use Initial U.S. Approval: 2007
Approved
Approval ID
a1f129ff-c0a4-ede7-ae9c-7a3cfa01fe12
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 15, 2023
Manufacturers
FDA
Almaject, Inc.
DUNS: 116626205
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Temsirolimus Injection
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72611-785
Application NumberANDA207383
Product Classification
M
Marketing Category
C73584
G
Generic Name
Temsirolimus Injection
Product Specifications
Effective DateAugust 14, 2018
FDA Product Classification