APPLICATION
ANDA074649
TYPE
ANDA
ORIGINAL APPROVAL
1996-10-03
LATEST ACTION
2020-02-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CARBAMAZEPINEPrescription
CARBAMAZEPINE 200MG · TABLET · ORAL
Approval history
2020-02-28Labeling · Supplement 34 · standardAP
2016-11-08Labeling · Supplement 29 · standardAP
2016-11-08Labeling · Supplement 27 · standardAP
2013-06-13Labeling · Supplement 23 · standardAP
2012-01-24Labeling · Supplement 21AP
2009-11-05Labeling · Supplement 19AP
2008-04-21Labeling · Supplement 15AP
2001-03-06Labeling · Supplement 8AP
2001-03-06Manufacturing (CMC) · Supplement 7AP
2001-02-28Labeling · Supplement 9AP
1999-09-22Labeling · Supplement 6AP
1999-03-11Manufacturing (CMC) · Supplement 4AP
1999-03-11Labeling · Supplement 5AP
1998-09-30Manufacturing (CMC) · Supplement 3AP
1998-09-30Labeling · Supplement 2AP
1997-05-27Manufacturing (CMC) · Supplement 1AP
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.