Levetiracetam
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. Levetiracetam Oral SolutionInitial U.S. Approval: 1999
Approved
Approval ID
3edcaae5-81bb-4a18-8bfd-834835187b13
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 15, 2020
Manufacturers
FDA
Morton Grove Pharmaceuticals, Inc.
DUNS: 801897505
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 Code60432-831
Application NumberANDA090028
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 15, 2020
Generic NameLevetiracetam
INGREDIENTS (10)
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
LEVETIRACETAMActive
Quantity: 100 mg in 1 mL
Code: 44YRR34555
Classification: ACTIB
AMMONIUM GLYCYRRHIZATEInactive
Code: 3VRD35U26C
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MALTITOLInactive
Code: D65DG142WK
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT