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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
Apotheca Inc.
DUNS: 051457844
Effective Date
July 6, 2016
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Atenolol(100 mg in 1 1)

Manufacturing Establishments1

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

Apotheca Inc.

Apotheca Inc.

051457844

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
12634-605
Application Number
ANDA076900
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
July 6, 2016
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
AtenololActive
Code: 50VV3VW0TIClass: ACTIBQuantity: 100 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
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