← FDA DRUG APPROVALS

FDA ANDA · ANDA090239

OXCARBAZEPINE

Sponsor: JUBILANT CADISTA

APPLICATION
ANDA090239
TYPE
ANDA
ORIGINAL APPROVAL
2010-01-25
LATEST ACTION
2015-01-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

OXCARBAZEPINEDiscontinued
OXCARBAZEPINE 600MG · TABLET · ORAL
OXCARBAZEPINEDiscontinued
OXCARBAZEPINE 150MG · TABLET · ORAL
OXCARBAZEPINEDiscontinued
OXCARBAZEPINE 300MG · TABLET · ORAL

Approval history

2015-01-20Labeling · Supplement 1AP
2015-01-20Labeling · Supplement 4 · standardAP
2010-01-25OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →