Drug Approval Package: TEMODAR

Company: Merck Sharp & Dohme LLC
Application Number: 021029Orig1s036,037,038;022277Orig1s017,018,019
Approval Date: 9/14/2023

Drugs@FDA information available about TEMODAR (021029)
Drugs@FDA information available about TEMODAR (022277)

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FDA Approval Letter and Labeling

• Approval Letter(s) (PDF)
• Printed Labeling (PDF)

FDA Application Review Files

• Multi-Discipline Review (PDF)
• Other Review(s) (PDF)

Date created: September 28, 2023

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