RecallHawk

FLUOXETINE HYDROCHLORIDE

SOMERSET THERAPS LLC

Summary

FDA approved FLUOXETINE HYDROCHLORIDE by SOMERSET THERAPS LLC. ANDA (Generic) approval (Labeling) on 2024-08-29. TABLET, ORAL.

Details

Source

Drug Approval

External ID

ANDA211477-3

Action Date

2024-08-29

Status

Approved

Category

drug

Product Code

ANDA (Generic)

Product Description

FLUOXETINE HYDROCHLORIDE, TABLET, ORAL. Application: ANDA211477

Context & Analysis

SOMERSET THERAPS LLC has 26 FDA actions in our database.

Frequently Asked Questions

How often does SOMERSET THERAPS LLC have FDA actions?

SOMERSET THERAPS LLC has 26 FDA actions in our database, including 0 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "ANDA211477-3" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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