DORAL
These highlights do not include all the information needed to use DORAL safely and effectively. See full prescribing information for DORAL . DORAL (quazepam) for oral use C-IV Initial U.S. Approval: 1985
Approved
Approval ID
9727e8b4-14f1-451d-9630-84eabc772e42
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 2023
Manufacturers
FDA
Galt Pharmaceuticals, LLC
DUNS: 079214973
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 Code61825-165
Application NumberNDA018708
Product Classification
M
Marketing Category
C73594
G
Generic Name
Quazepam
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 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
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
QUAZEPAMActive
Quantity: 15 mg in 1 1
Code: JF8V0828ZI
Classification: ACTIB
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT