APPLICATION
ANDA070231
TYPE
ANDA
ORIGINAL APPROVAL
1986-08-14
LATEST ACTION
2000-10-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CARBAMAZEPINEDiscontinued
CARBAMAZEPINE 200MG · TABLET · ORAL
Approval history
2000-10-05Labeling · Supplement 11AP
1998-12-30Labeling · Supplement 10AP
1998-11-23Manufacturing (CMC) · Supplement 9AP
1997-08-08Labeling · Supplement 8AP
1993-02-22Manufacturing (CMC) · Supplement 7AP
1990-12-10Labeling · Supplement 6AP
1990-03-07Labeling · Supplement 5AP
1989-10-05Labeling · Supplement 3AP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.