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Atenolol

Approved
Approval ID

f318707a-4fb9-604c-e053-2a95a90ae973

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 25, 2023

Manufacturers
FDA

Northwind Pharmaceuticals, LLC

DUNS: 036986393

Products 1

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

atenolol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51655-491
Application NumberANDA073457
Product Classification
M
Marketing Category
C73584
G
Generic Name
atenolol
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 25, 2023
FDA Product Classification

INGREDIENTS (6)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ATENOLOLActive
Quantity: 25 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB

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Atenolol - FDA Drug Approval Details