FDA Product

Duloxetine HCL DR

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Duloxetine HCL DR

FDA Product Code

80425-0014

Regulatory Information

NDC Product Code

80425-0014

Application Number

ANDA090778

Marketing Category

C73584

Effective Date

November 17, 2022

Territorial Authority

USA

FDA Title

Duloxetine HCL DR 30mg Capsules

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

6

Company Information

ManufacturerAdvanced Rx Pharmacy of Tennessee, LLC

DUNS Number

117023142

Active Ingredients

DULOXETINE HYDROCHLORIDE

Quantity: 30 mg in 1 1

Code: 9044SC542W

Class Code: ACTIM

Active Moieties

DULOXETINE

Code: O5TNM5N07U

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