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FDA Approval

Atenolol and Chlorthalidone

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

FDA Approval Summary

Company
Effective Date
November 22, 2013
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Atenolol(50 mg in 1 1)
Chlorthalidone(25 mg in 1 1)

Products1

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

Atenolol and Chlorthalidone

Product Details

NDC Product Code
33261-942
Application Number
ANDA073665
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
November 22, 2013
AtenololActive
Code: 50VV3VW0TIClass: ACTIBQuantity: 50 mg in 1 1
Code: Q0MQD1073QClass: ACTIBQuantity: 25 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POVIDONE K29/32Inactive
Code: 390RMW2PEQClass: IACT
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