Diazepam
DIAZEPAM ORAL SOLUTION, CIV
Approved
Approval ID
5051e98b-3817-61aa-dba8-bd8be2f0c086
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 3, 1987
Manufacturers
FDA
Atlantic Biologicals Corps
DUNS: 047437707
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Diazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code17856-3188
Application NumberANDA070928
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diazepam
Product Specifications
Route of AdministrationORAL
Effective DateApril 3, 1987
FDA Product Classification
INGREDIENTS (9)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
DIAZEPAMActive
Quantity: 5 mg in 5 mL
Code: Q3JTX2Q7TU
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT