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FDA Approval

Atenolol

CompanyProficient Rx LP (DUNS: 079196022)

Effective Date

October 1, 2019

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Atenolol(25 mg in 1 1)

Manufacturing Establishments (1)

Proficient Rx LP

Labeler

Proficient Rx LP

DUNS Number

079196022

Products (1)

Atenolol

NDC Product Code

71205-096

Application Number

ANDA077443

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 1, 2018

Ingredients

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

titanium dioxideInactive

Code: 15FIX9V2JPClass: IACT

glycerinInactive

Code: PDC6A3C0OXClass: IACT

Code: 50VV3VW0TIClass: ACTIBQuantity: 25 mg in 1 1

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