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OXCARBAZEPINE EXTENDED RELEASE TABLETS

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: LUPIN LIMITED · Approved 2025-06-06

Drug application

FDA Application #
ANDA219404
Application type
Abbreviated New Drug Application (Generic)
Brand name
OXCARBAZEPINE EXTENDED RELEASE TABLETS
Generic name
Oxcarbazepine
Active ingredients
OXCARBAZEPINE
Dosage form
TABLET
Route
EXTENDED RELEASE
Marketing status
None (Tentative Approval)
Sponsor
LUPIN LIMITED
First approval
2025-06-06

Source

Authoritative
Drugs@FDA application overview
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