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FDA ANDA · ANDA209801

PERAMPANEL

Sponsor: TEVA PHARMS USA INC

APPLICATION
ANDA209801
TYPE
ANDA
ORIGINAL APPROVAL
2025-05-23
LATEST ACTION
2025-05-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

PERAMPANELPrescription
PERAMPANEL 12MG · TABLET · ORAL
PERAMPANELPrescription
PERAMPANEL 8MG · TABLET · ORAL
PERAMPANELPrescription
PERAMPANEL 4MG · TABLET · ORAL
PERAMPANELPrescription
PERAMPANEL 10MG · TABLET · ORAL
PERAMPANELPrescription
PERAMPANEL 6MG · TABLET · ORAL
PERAMPANELPrescription
PERAMPANEL 2MG · TABLET · ORAL

Approval history

2025-05-23UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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