← FDA DRUG APPROVALS

FDA ANDA · ANDA216481

ESLICARBAZEPINE ACETATE

Sponsor: AUROBINDO PHARMA LTD

APPLICATION
ANDA216481
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

ESLICARBAZEPINE ACETATENone (Tentative Approval)
ESLICARBAZEPINE ACETATE 200MG · TABLET · ORAL
ESLICARBAZEPINE ACETATENone (Tentative Approval)
ESLICARBAZEPINE ACETATE 400MG · TABLET · ORAL
ESLICARBAZEPINE ACETATENone (Tentative Approval)
ESLICARBAZEPINE ACETATE 600MG · TABLET · ORAL

Approval history

2023-07-31UNKNOWN · Original · standard — Letter ↗TA
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 →