MedPath

Lorazepam

LORAZEPAM ORAL CONCENTRATE USP, 2 mg per mL, CIV

Approved
Approval ID

711b60a3-028d-41d4-aa17-8f976e6df23e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 11, 2022

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.

Lorazepam

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0121-0770
Application NumberANDA090260
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lorazepam
Product Specifications
Route of AdministrationORAL
Effective DateAugust 11, 2022
FDA Product Classification

INGREDIENTS (1)

LORAZEPAMActive
Quantity: 2 mg in 1 mL
Code: O26FZP769L
Classification: ACTIB

MedPath

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

© 2025 MedPath, Inc. All rights reserved.