APPLICATION
ANDA218442
TYPE
ANDA
ROUTE
EXTENDED RELEASE
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)
Products
OXCARBAZEPINENone (Tentative Approval)
OXCARBAZEPINE 300MG · TABLET · EXTENDED RELEASE
OXCARBAZEPINENone (Tentative Approval)
OXCARBAZEPINE 600MG · TABLET · EXTENDED RELEASE
Approval history
2025-01-08UNKNOWN · Original · standardTA
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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