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OXCARBAZEPINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVAST LABS LTD · Approved 2025-06-04

Drug application

FDA Application #
ANDA218724
Application type
Abbreviated New Drug Application (Generic)
Brand name
OXCARBAZEPINE
Generic name
Oxcarbazepine
Active ingredients
OXCARBAZEPINE
Dosage form
TABLET, EXTENDED RELEASE
Route
—
Marketing status
None (Tentative Approval)
Sponsor
NOVAST LABS LTD
First approval
2025-06-04

Source

Authoritative
Drugs@FDA application overview
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