← FDA DRUG APPROVALS

FDA NDA · NDA216774

ALVAIZ

eltrombopag

Sponsor: TEVA PHARMS INC

APPLICATION
NDA216774
TYPE
NDA
ORIGINAL APPROVAL
2023-11-29
LATEST ACTION
2026-01-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ALVAIZ · ReferencePrescription
ELTROMBOPAG CHOLINE EQ 36MG BASE · TABLET · ORAL
ALVAIZ · ReferencePrescription
ELTROMBOPAG CHOLINE EQ 9MG BASE · TABLET · ORAL
ALVAIZ · ReferencePrescription
ELTROMBOPAG CHOLINE EQ 54MG BASE · TABLET · ORAL
ALVAIZ · ReferencePrescription
ELTROMBOPAG CHOLINE EQ 18MG BASE · TABLET · ORAL

Approval history

2026-01-15Labeling · Supplement 6 · standard — Letter ↗AP
2023-11-29Type 2 - New Active Ingredient · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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