RecallHawk

FLUOXETINE (FLUOXETINE HYDROCHLORIDE)

INVENTIA HLTHCARE

Summary

FDA approved FLUOXETINE (FLUOXETINE HYDROCHLORIDE) by INVENTIA HLTHCARE. ANDA (Generic) approval (Labeling) on 2025-09-26. TABLET, ORAL.

Details

Source

Drug Approval

External ID

ANDA209695-8

Action Date

2025-09-26

Status

Approved

Category

drug

Product Code

ANDA (Generic)

Product Description

FLUOXETINE (generic: FLUOXETINE HYDROCHLORIDE), TABLET, ORAL. Application: ANDA209695

Context & Analysis

INVENTIA HLTHCARE has 2 FDA actions in our database.

Frequently Asked Questions

How often does INVENTIA HLTHCARE have FDA actions?

INVENTIA HLTHCARE has 2 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 "ANDA209695-8" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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