← FDA DRUG APPROVALS

FDA ANDA · ANDA205444

OXCARBAZEPINE

Sponsor: ACTAVIS LABS FL INC

APPLICATION
ANDA205444
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
None (Tentative Approval)

Products

OXCARBAZEPINENone (Tentative Approval)
OXCARBAZEPINE 600MG · TABLET, EXTENDED RELEASE · ORAL
OXCARBAZEPINENone (Tentative Approval)
OXCARBAZEPINE 150MG · TABLET, EXTENDED RELEASE · ORAL
OXCARBAZEPINENone (Tentative Approval)
OXCARBAZEPINE 300MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2018-07-19UNKNOWN · 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 →