← FDA Drug Approvals (Drugs@FDA)
ZEJULA
NDA · New Drug Application · Sponsor: GLAXOSMITHKLINE · Approved 2023-04-26
Drug application
- FDA Application #
NDA214876- Application type
- New Drug Application
- Brand name
- ZEJULA
- Generic name
- NIRAPARIB
- Active ingredients
- NIRAPARIB TOSYLATE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- GLAXOSMITHKLINE
- Manufacturer
- GlaxoSmithKline LLC
- First approval
- 2023-04-26
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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