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FDA Approval

Eszopiclone

CompanyAdvanced Rx Pharmacy of Tennessee, LLC (DUNS: 117023142)

Effective Date

January 19, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Eszopiclone(3 mg in 1 1)

Manufacturing Establishments (1)

Advanced Rx Pharmacy of Tennessee, LLC

Labeler

Advanced Rx Pharmacy of Tennessee, LLC

DUNS Number

117023142

Products (1)

Eszopiclone

NDC Product Code

80425-0067

Application Number

ANDA091024

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 19, 2023

Ingredients

EszopicloneActive

Code: UZX80K71OEClass: ACTIBQuantity: 3 mg in 1 1

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