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Atenolol

Atenolol Tablets, USP

Approved
Approval ID

79000ef8-702c-47ec-aafc-9bc1dfd83e77

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 24, 2010

Manufacturers
FDA

State of Florida DOH Central Pharmacy

DUNS: 829348114

Products 3

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

Atenolol

PRODUCT DETAILS

NDC Product Code53808-0730
Application NumberANDA076900
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 24, 2010
Generic NameAtenolol

INGREDIENTS (7)

POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
ATENOLOLActive
Quantity: 25 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT

Atenolol

PRODUCT DETAILS

NDC Product Code53808-0207
Application NumberANDA076900
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 24, 2010
Generic NameAtenolol

INGREDIENTS (7)

ATENOLOLActive
Quantity: 50 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

Atenolol

PRODUCT DETAILS

NDC Product Code53808-0344
Application NumberANDA076900
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 24, 2010
Generic NameAtenolol

INGREDIENTS (7)

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
ATENOLOLActive
Quantity: 100 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
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Atenolol - FDA Approval | MedPath