← FDA DRUG APPROVALS

FDA ANDA · ANDA078746

CARBAMAZEPINE

Sponsor: TEVA PHARMS USA

APPLICATION
ANDA078746
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
None (Tentative Approval)

Products

CARBAMAZEPINENone (Tentative Approval)
CARBAMAZEPINE 300MG · CAPSULE, EXTENDED RELEASE · ORAL
CARBAMAZEPINENone (Tentative Approval)
CARBAMAZEPINE 100MG · CAPSULE, EXTENDED RELEASE · ORAL
CARBAMAZEPINENone (Tentative Approval)
CARBAMAZEPINE 200MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2012-09-20OriginalTA
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 →