LEVETIRACETAM
Levetiracetam Oral Solution 100 mg/mL
Approved
Approval ID
94a972db-11b3-419e-9410-8d923c9f1489
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 26, 2014
Manufacturers
FDA
Pharmaceutical Associates, Inc.
DUNS: 044940096
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
LEVETIRACETAM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0121-4802
Application NumberANDA090028
Product Classification
M
Marketing Category
C73584
G
Generic Name
LEVETIRACETAM
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 27, 2014
FDA Product Classification
INGREDIENTS (10)
LEVETIRACETAMActive
Quantity: 100 mg in 1 mL
Code: 44YRR34555
Classification: ACTIB
AMMONIUM GLYCYRRHIZATEInactive
Code: 3VRD35U26C
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
MALTITOLInactive
Code: D65DG142WK
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT