FDA ANDA · ANDA075948
CARBAMAZEPINE
Sponsor: APOTEX
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APPLICATION
ANDA075948
TYPE
ANDA
ORIGINAL APPROVAL
2002-02-27
LATEST ACTION
2026-10-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CARBAMAZEPINEPrescription
CARBAMAZEPINE 200MG · TABLET · ORAL
Approval history
2026-10-14Labeling · Supplement 23 · standardAP
2026-03-06Labeling · Supplement 22 · standardAP
2024-01-29Labeling · Supplement 21 · standardAP
2022-11-08Labeling · Supplement 19 · standardAP
2020-04-20Labeling · Supplement 14 · standardAP
2020-04-20Labeling · Supplement 12 · standardAP
2015-02-18Labeling · Supplement 10 · standardAP
2015-02-18Labeling · Supplement 8 · standardAP
2015-02-18Labeling · Supplement 11 · standardAP
2015-02-18Labeling · Supplement 9 · standardAP
2011-11-04REMS · Supplement 7AP
2009-11-25Labeling · Supplement 6AP
2008-07-28Labeling · Supplement 3AP
2002-10-15Manufacturing (CMC) · Supplement 1AP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →