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FDA ANDA · ANDA211238

ESLICARBAZEPINE ACETATE

Sponsor: DR REDDYS

APPLICATION
ANDA211238
TYPE
ANDA
ORIGINAL APPROVAL
2021-06-29
LATEST ACTION
2021-06-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ESLICARBAZEPINE ACETATEPrescription
ESLICARBAZEPINE ACETATE 600MG · TABLET · ORAL
ESLICARBAZEPINE ACETATEPrescription
ESLICARBAZEPINE ACETATE 200MG · TABLET · ORAL
ESLICARBAZEPINE ACETATEPrescription
ESLICARBAZEPINE ACETATE 800MG · TABLET · ORAL
ESLICARBAZEPINE ACETATEPrescription
ESLICARBAZEPINE ACETATE 400MG · TABLET · ORAL

Approval history

2021-06-29UNKNOWN · Original · standardLetterAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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