MedPath

Levetiracetam

LEVETIRACETAM oral solution These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. Initial U.S. Approval: 1999

Approved
Approval ID

9679202b-2208-43e5-841b-2faab0e516f3

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 22, 2019

Manufacturers
FDA

Lohxa

DUNS: 079872715

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Levetiracetam

PRODUCT DETAILS

NDC Product Code70166-081
Application NumberANDA203052
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 22, 2019
Generic NameLevetiracetam

INGREDIENTS (10)

ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
GLYCYRRHIZINInactive
Code: 6FO62043WK
Classification: IACT
MALTITOLInactive
Code: D65DG142WK
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
LEVETIRACETAMActive
Quantity: 100 mg in 1 mL
Code: 44YRR34555
Classification: ACTIB

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Levetiracetam - FDA Drug Approval Details