APPLICATION
ANDA219638
TYPE
ANDA
ORIGINAL APPROVAL
2026-01-14
LATEST ACTION
2026-01-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval), Prescription
Products
ELTROMBOPAG OLAMINENone (Tentative Approval)
ELTROMBOPAG OLAMINE 25MG · TABLET
ELTROMBOPAG OLAMINEPrescription
ELTROMBOPAG OLAMINE EQ 50MG ACID · TABLET · ORAL
ELTROMBOPAG OLAMINEPrescription
ELTROMBOPAG OLAMINE EQ 12.5MG ACID · TABLET · ORAL
ELTROMBOPAG OLAMINEPrescription
ELTROMBOPAG OLAMINE EQ 75MG ACID · TABLET · ORAL
ELTROMBOPAG OLAMINEPrescription
ELTROMBOPAG OLAMINE EQ 25MG ACID · TABLET · ORAL
Approval history
2026-01-14UNKNOWN · Original · standardAP
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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