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ESLICARBAZEPINE ACETATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2023-10-06

Drug application

FDA Application #
ANDA211199
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
Prescription
Sponsor
ALKEM LABS LTD
Manufacturer
Ascend Laboratories, LLC
First approval
2023-10-06

Source

Authoritative
Drugs@FDA application overview
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