APPLICATION
ANDA076729
TYPE
ANDA
ORIGINAL APPROVAL
2004-09-20
LATEST ACTION
2020-02-28
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription
Products
TERILPrescription
CARBAMAZEPINE 100MG/5ML · SUSPENSION · ORAL
Approval history
2020-02-28Labeling · Supplement 17 · standardAP
2016-11-08Labeling · Supplement 13 · standardAP
2016-11-08Labeling · Supplement 11 · standardAP
2013-06-13Labeling · Supplement 9 · standardAP
2012-01-24Labeling · Supplement 8AP
2010-01-27Labeling · Supplement 4AP
2008-04-17Labeling · Supplement 2AP
2004-09-20OriginalAP
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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