MedPath

Atenolol

Rx Only

Approved
Approval ID

b8585313-58f6-42af-bab7-e524ccdacd08

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 11, 2009

Manufacturers
FDA

MedVantx, Inc.

DUNS: 806427725

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 Code66116-401
Application NumberANDA078254
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atenolol
Product Specifications
Route of AdministrationORAL
Effective DateDecember 11, 2009
FDA Product Classification

INGREDIENTS (5)

POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
AtenololActive
Quantity: 50 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

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Atenolol - FDA Drug Approval Details