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FDA Approval

Atenolol

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
January 25, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Atenolol(25 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Northwind Pharmaceuticals, LLC

036986393

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Northwind Pharmaceuticals, LLC

Northwind Pharmaceuticals, LLC

Northwind Pharmaceuticals, LLC

036986393

Products1

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

Atenolol

Product Details

NDC Product Code
51655-491
Application Number
ANDA073457
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 25, 2023
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
AtenololActive
Code: 50VV3VW0TIClass: ACTIBQuantity: 25 mg in 1 1
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