ZEJULA (NIRAPARIB)
Summary
FDA approved ZEJULA (NIRAPARIB) by GLAXOSMITHKLINE. NDA (New Drug) approval (Labeling) on 2026-03-27. TABLET, ORAL.
Details
Source
Drug Approval
External ID
NDA214876-6
Action Date
2026-03-27
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
ZEJULA (generic: NIRAPARIB), TABLET, ORAL. Application: NDA214876
Company
Context & Analysis
GLAXOSMITHKLINE has 15 FDA actions in our database.
Frequently Asked Questions
How often does GLAXOSMITHKLINE have FDA actions?
GLAXOSMITHKLINE has 15 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 "NDA214876-6" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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