← FDA DRUG APPROVALS

FDA ANDA · ANDA216281

ELTROMBOPAG

Sponsor: ZYDUS PHARMS

APPLICATION
ANDA216281
TYPE
ANDA
ORIGINAL APPROVAL
2026-01-14
LATEST ACTION
2026-01-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ELTROMBOPAG OLAMINEPrescription
ELTROMBOPAG OLAMINE EQ 75MG ACID · TABLET · ORAL
ELTROMBOPAG OLAMINEPrescription
ELTROMBOPAG OLAMINE EQ 25MG ACID · TABLET · ORAL
ELTROMBOPAG OLAMINEPrescription
ELTROMBOPAG OLAMINE EQ 50MG ACID · TABLET · ORAL
ELTROMBOPAG OLAMINEPrescription
ELTROMBOPAG OLAMINE EQ 12.5MG ACID · TABLET · ORAL

Approval history

2026-01-14UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →