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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
Major Pharmaceuticals
DUNS: 191427277
Effective Date
November 8, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Atenolol(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

Product Details

NDC Product Code
0904-7187
Application Number
ANDA078512
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
November 8, 2021
AtenololActive
Code: 50VV3VW0TIClass: ACTIBQuantity: 25 mg in 1 1
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MKClass: IACT
POVIDONE K90Inactive
Code: RDH86HJV5ZClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
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