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Diazepam

Diazepam Tablets, USP2 mg, 5 mg and 10 mg Rx only

Approved
Approval ID

01f04ee4-fff9-499a-8213-984e16368084

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 25, 2024

Manufacturers
FDA

A-S Medication Solutions

DUNS: 830016429

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 Code50090-3390
Application NumberANDA070325
Product Classification
M
Marketing Category
C73584
G
Generic Name
diazepam
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2017
FDA Product Classification

INGREDIENTS (6)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DIAZEPAMActive
Quantity: 2 mg in 1 1
Code: Q3JTX2Q7TU
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT

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Diazepam - FDA Drug Approval Details