APPLICATION
ANDA075714
TYPE
ANDA
ORIGINAL APPROVAL
2002-06-05
LATEST ACTION
2024-01-29
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription
Products
CARBAMAZEPINEPrescription
CARBAMAZEPINE 100MG/5ML · SUSPENSION · ORAL
Approval history
2024-01-29Labeling · Supplement 18 · standardAP
2012-01-26Labeling · Supplement 7AP
2009-12-15Labeling · Supplement 5AP
2008-03-14Labeling · Supplement 4AP
2008-01-11Labeling · Supplement 3AP
2004-04-09Labeling · Supplement 2AP
2003-11-05Labeling · 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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