Diazepam
Diazepam Tablets USP C-IV
Approved
Approval ID
f84b28ff-aae1-4796-a8f0-e06e146235a2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 21, 2020
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Diazepam
PRODUCT DETAILS
NDC Product Code71610-427
Application NumberANDA071136
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 2, 2020
Generic NameDiazepam
INGREDIENTS (5)
Anhydrous LactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
DiazepamActive
Quantity: 10 mg in 1 1
Code: Q3JTX2Q7TU
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT