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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
- Machine
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