APPLICATION
ANDA073524
TYPE
ANDA
ORIGINAL APPROVAL
1992-07-29
LATEST ACTION
2024-07-22
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Prescription
Products
EPITOLPrescription
CARBAMAZEPINE 100MG · TABLET, CHEWABLE · ORAL
Approval history
2024-07-22Labeling · Supplement 54 · standardAP
2022-11-21Labeling · Supplement 53 · standardAP
2020-02-27Labeling · Supplement 48 · standardAP
2020-02-27Labeling · Supplement 45 · standardAP
2015-02-06Labeling · Supplement 42 · standardAP
2015-02-06Labeling · Supplement 43 · standardAP
2014-03-10Labeling · Supplement 38 · standardAP
2014-03-10Labeling · Supplement 39 · standardAP
2012-10-23Labeling · Supplement 37 · standardAP
2011-05-31Labeling · Supplement 36AP
2011-01-21Labeling · Supplement 35AP
2010-03-17Labeling · Supplement 34AP
2009-11-16Labeling · Supplement 31AP
2008-03-26Labeling · Supplement 30AP
2002-12-05Labeling · Supplement 27AP
2002-05-08Labeling · Supplement 24AP
2002-04-23Manufacturing (CMC) · Supplement 25AP
2000-05-01Manufacturing (CMC) · Supplement 23AP
1999-12-02Manufacturing (CMC) · Supplement 22AP
1999-12-02Manufacturing (CMC) · Supplement 21AP
1999-08-13Labeling · Supplement 11AP
1999-02-12Manufacturing (CMC) · Supplement 10AP
1999-02-12Manufacturing (CMC) · Supplement 9AP
1997-09-24Labeling · Supplement 8AP
1997-02-04Manufacturing (CMC) · Supplement 6AP
1996-12-02Manufacturing (CMC) · Supplement 5AP
1996-07-25Manufacturing (CMC) · Supplement 3AP
1995-02-09Labeling · Supplement 2AP
1992-07-29OriginalAP
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.