Lorazepam
Lorazepam Oral Concentrate USP, 2 mg per mL, CIV
Approved
Approval ID
093a6f7b-1ea8-4467-bd0f-5f7d29067d32
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 4, 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.
Lorazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70166-260
Application NumberANDA091383
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lorazepam
Product Specifications
Route of AdministrationORAL
Effective DateNovember 4, 2019
FDA Product Classification
INGREDIENTS (5)
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
LORAZEPAMActive
Quantity: 2 mg in 1 mL
Code: O26FZP769L
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT