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ESLICARBAZEPINE ACETATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA LTD · Approved 2023-07-31

Drug application

FDA Application #
ANDA216481
Application type
Abbreviated New Drug Application (Generic)
Brand name
ESLICARBAZEPINE ACETATE
Generic name
Eslicarbazepine Acetate
Active ingredients
ESLICARBAZEPINE ACETATE
Dosage form
TABLET
Route
ORAL
Marketing status
None (Tentative Approval)
Sponsor
AUROBINDO PHARMA LTD
First approval
2023-07-31

Source

Authoritative
Drugs@FDA application overview
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