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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 2, 2020
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Atenolol(25 mg in 1 1)

Manufacturing Establishments1

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

St. Mary's Medical Park Pharmacy

St. Mary's Medical Park Pharmacy

063050751

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
60760-256
Application Number
ANDA074052
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 2, 2020
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
AtenololActive
Code: 50VV3VW0TIClass: ACTIBQuantity: 25 mg in 1 1
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