APPLICATION
ANDA202961
TYPE
ANDA
ORIGINAL APPROVAL
2012-09-17
LATEST ACTION
2025-02-07
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription
Products
OXCARBAZEPINEPrescription
OXCARBAZEPINE 300MG/5ML · SUSPENSION · ORAL
Approval history
2025-02-07Labeling · Supplement 20 · standardAP
2023-03-01Manufacturing (CMC) · Supplement 16 · unknownAP
2022-11-01Labeling · Supplement 6 · standardAP
2022-11-01Labeling · Supplement 4 · standardAP
2022-11-01Labeling · Supplement 5 · standardAP
2015-02-04Labeling · Supplement 2 · standardAP
2015-02-04Labeling · Supplement 1 · standardAP
2012-09-17UNKNOWN · OriginalAP
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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