MedPath

Quazepam

These highlights do not include all the information needed to use QUAZEPAM TABLETS safely and effectively. See full prescribing information for QUAZEPAM TABLETS. QUAZEPAM TABLETS for oral use C-IV Initial U.S. Approval: 1985

Approved
Approval ID

f7d63f3f-5303-48ab-bce2-35fd62c45799

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 22, 2023

Manufacturers
FDA

Atland Pharmaceuticals, LLC

DUNS: 080942150

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Quazepam

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71993-265
Application NumberNDA018708
Product Classification
M
Marketing Category
C73605
G
Generic Name
Quazepam
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 22, 2023
FDA Product Classification

INGREDIENTS (8)

POWDERED CELLULOSEInactive
Code: SMD1X3XO9M
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
QUAZEPAMActive
Quantity: 15 mg in 1 1
Code: JF8V0828ZI
Classification: ACTIB

MedPath

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

© 2025 MedPath, Inc. All rights reserved.

Quazepam - FDA Drug Approval Details