APPLICATION
ANDA075712
TYPE
ANDA
ORIGINAL APPROVAL
2001-07-05
LATEST ACTION
2026-03-20
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Prescription
Products
CARBAMAZEPINEPrescription
CARBAMAZEPINE 100MG · TABLET, CHEWABLE · ORAL
Approval history
2026-03-20Labeling · Supplement 39 · standardAP
2025-01-27Labeling · Supplement 36 · standardAP
2021-03-03Labeling · Supplement 29 · standardAP
2021-03-03Labeling · Supplement 32 · standardAP
2015-01-20Labeling · Supplement 27 · standardAP
2015-01-20Labeling · Supplement 26 · standardAP
2014-02-19Labeling · Supplement 23 · standardAP
2014-02-19Labeling · Supplement 24 · standardAP
2012-06-19Labeling · Supplement 22 · standardAP
2011-09-27Labeling · Supplement 18AP
2010-05-27Labeling · Supplement 15AP
2010-02-23Labeling · Supplement 16AP
2010-02-23Labeling · Supplement 14AP
2008-02-11Labeling · Supplement 10AP
2007-12-17Labeling · Supplement 9AP
2002-10-01Manufacturing (CMC) · Supplement 2AP
2002-10-01Labeling · Supplement 3AP
2001-10-25Manufacturing (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.
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