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Atenolol

Atenolol Tablets, USP

Approved
Approval ID

200e9378-f0be-4d8c-a243-9283cd4f1977

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 27, 2011

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

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 Code42254-046
Application NumberANDA077877
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atenolol
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2011
FDA Product Classification

INGREDIENTS (7)

ATENOLOLActive
Quantity: 100 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT

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Atenolol - FDA Drug Approval Details