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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218178
Company: MSN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PERAMPANEL PERAMPANEL 2MG TABLET;ORAL Prescription AB No No
PERAMPANEL PERAMPANEL 4MG TABLET;ORAL Prescription AB No No
PERAMPANEL PERAMPANEL 6MG TABLET;ORAL Prescription AB No No
PERAMPANEL PERAMPANEL 8MG TABLET;ORAL Prescription AB No No
PERAMPANEL PERAMPANEL 10MG TABLET;ORAL Prescription AB No No
PERAMPANEL PERAMPANEL 12MG TABLET;ORAL Prescription AB No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/25/2025 ORIG-1 Approval STANDARD

Label is not available on this site.

PERAMPANEL

TABLET;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FYCOMPA PERAMPANEL 2MG TABLET;ORAL Prescription Yes AB 202834 CATALYST PHARMS
PERAMPANEL PERAMPANEL 2MG TABLET;ORAL Prescription No AB 218178 MSN
PERAMPANEL PERAMPANEL 2MG TABLET;ORAL Prescription No AB 209538 TARO
PERAMPANEL PERAMPANEL 2MG TABLET;ORAL Prescription No AB 209801 TEVA PHARMS USA INC

TABLET;ORAL; 4MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FYCOMPA PERAMPANEL 4MG TABLET;ORAL Prescription Yes AB 202834 CATALYST PHARMS
PERAMPANEL PERAMPANEL 4MG TABLET;ORAL Prescription No AB 218178 MSN
PERAMPANEL PERAMPANEL 4MG TABLET;ORAL Prescription No AB 209538 TARO
PERAMPANEL PERAMPANEL 4MG TABLET;ORAL Prescription No AB 209801 TEVA PHARMS USA INC

TABLET;ORAL; 6MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FYCOMPA PERAMPANEL 6MG TABLET;ORAL Prescription Yes AB 202834 CATALYST PHARMS
PERAMPANEL PERAMPANEL 6MG TABLET;ORAL Prescription No AB 218178 MSN
PERAMPANEL PERAMPANEL 6MG TABLET;ORAL Prescription No AB 209538 TARO
PERAMPANEL PERAMPANEL 6MG TABLET;ORAL Prescription No AB 209801 TEVA PHARMS USA INC

TABLET;ORAL; 8MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FYCOMPA PERAMPANEL 8MG TABLET;ORAL Prescription Yes AB 202834 CATALYST PHARMS
PERAMPANEL PERAMPANEL 8MG TABLET;ORAL Prescription No AB 218178 MSN
PERAMPANEL PERAMPANEL 8MG TABLET;ORAL Prescription No AB 209538 TARO
PERAMPANEL PERAMPANEL 8MG TABLET;ORAL Prescription No AB 209801 TEVA PHARMS USA INC

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FYCOMPA PERAMPANEL 10MG TABLET;ORAL Prescription Yes AB 202834 CATALYST PHARMS
PERAMPANEL PERAMPANEL 10MG TABLET;ORAL Prescription No AB 218178 MSN
PERAMPANEL PERAMPANEL 10MG TABLET;ORAL Prescription No AB 209538 TARO
PERAMPANEL PERAMPANEL 10MG TABLET;ORAL Prescription No AB 209801 TEVA PHARMS USA INC

TABLET;ORAL; 12MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FYCOMPA PERAMPANEL 12MG TABLET;ORAL Prescription Yes AB 202834 CATALYST PHARMS
PERAMPANEL PERAMPANEL 12MG TABLET;ORAL Prescription No AB 218178 MSN
PERAMPANEL PERAMPANEL 12MG TABLET;ORAL Prescription No AB 209538 TARO
PERAMPANEL PERAMPANEL 12MG TABLET;ORAL Prescription No AB 209801 TEVA PHARMS USA INC
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