APPLICATION
ANDA075687
TYPE
ANDA
ORIGINAL APPROVAL
2000-10-24
LATEST ACTION
2020-02-28
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Prescription
Products
CARBAMAZEPINEPrescription
CARBAMAZEPINE 100MG · TABLET, CHEWABLE · ORAL
CARBAMAZEPINEPrescription
CARBAMAZEPINE 200MG · TABLET, CHEWABLE · ORAL
Approval history
2020-02-28Labeling · Supplement 28 · standardAP
2016-11-08Labeling · Supplement 22 · standardAP
2016-11-08Labeling · Supplement 23 · standardAP
2013-06-13Labeling · Supplement 17 · standardAP
2012-01-24Labeling · Supplement 15AP
2010-01-27Labeling · Supplement 12AP
2008-04-17Labeling · Supplement 11AP
2002-07-29Manufacturing (CMC) · Supplement 1AP
2002-07-29Labeling · Supplement 2AP
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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