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FDA Approval

ORSERDU

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
November 21, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Elacestrant(86 mg in 1 1)

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ORSERDU

Product Details

NDC Product Code
72187-0101
Application Number
NDA217639
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
February 8, 2023
Code: FM6A2627A8Class: ACTIMQuantity: 86 mg in 1 1

ORSERDU

Product Details

NDC Product Code
72187-0102
Application Number
NDA217639
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
February 8, 2023
Code: FM6A2627A8Class: ACTIMQuantity: 345 mg in 1 1
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