Lorazepam
Lorazepam Oral Concentrate, USP CIV
Approved
Approval ID
73bfaeab-94db-48c2-a194-8b173025de78
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 13, 2023
Manufacturers
FDA
Akorn
DUNS: 117696873
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lorazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50383-705
Application NumberANDA200169
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lorazepam
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 13, 2023
FDA Product Classification
INGREDIENTS (3)
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
LORAZEPAMActive
Quantity: 2 mg in 1 mL
Code: O26FZP769L
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT