TEMODAR (TEMOZOLOMIDE)
Summary
FDA approved TEMODAR (TEMOZOLOMIDE) by MERCK SHARP DOHME. NDA (New Drug) approval (Efficacy) on 2023-09-14. CAPSULE, ORAL.
Details
Source
Drug Approval
External ID
NDA021029-37
Action Date
2023-09-14
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
TEMODAR (generic: TEMOZOLOMIDE), CAPSULE, ORAL. Application: NDA021029
Company
Context & Analysis
MERCK SHARP DOHME has 5 FDA actions in our database.
Frequently Asked Questions
How often does MERCK SHARP DOHME have FDA actions?
MERCK SHARP DOHME has 5 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA021029-37" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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