Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.
OXCARBAZEPINE EXTENDED RELEASE TABLETS
ANDATentative Approval
OXCARBAZEPINE | A219404 | LUPIN LIMITED
Products (2)
Sort:
#002 — 300MG
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TABLET;EXTENDED RELEASE | TA Date: 2025-06-06 00:00:00
No patent or exclusivity listings for this strength.
#003 — 600MG
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TABLET;EXTENDED RELEASE | TA Date: 2025-06-06 00:00:00