ORSERDU
These highlights do not include all the information needed to use ORSERDU safely and effectively. See full prescribing information for ORSERDU. ORSERDU™ (elacestrant) tablets, for oral use Initial U.S. Approval: 2023
Approved
Approval ID
aa66ae5c-2bd2-4444-8178-b55651e054ef
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 21, 2023
Manufacturers
FDA
Stemline Therapeutics, Inc.
DUNS: 139606136
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Elacestrant
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72187-0101
Application NumberNDA217639
Product Classification
M
Marketing Category
C73594
G
Generic Name
Elacestrant
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 8, 2023
FDA Product Classification
INGREDIENTS (1)
ELACESTRANTActive
Quantity: 86 mg in 1 1
Code: FM6A2627A8
Classification: ACTIM
Elacestrant
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72187-0102
Application NumberNDA217639
Product Classification
M
Marketing Category
C73594
G
Generic Name
Elacestrant
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 8, 2023
FDA Product Classification
INGREDIENTS (1)
ELACESTRANTActive
Quantity: 345 mg in 1 1
Code: FM6A2627A8
Classification: ACTIM