RecallHawk

Summary

FDA approved FLUOXETINE by AUROBINDO PHARMA LTD. ANDA (Generic) approval (Manufacturing (CMC)) on 2026-01-15. TABLET, ORAL.

Details

Source

Drug Approval

External ID

ANDA213265-5

Action Date

2026-01-15

Status

Approved

Category

drug

Product Code

ANDA (Generic)

Product Description

FLUOXETINE, TABLET, ORAL. Application: ANDA213265

Context & Analysis

AUROBINDO PHARMA LTD has 77 FDA actions in our database.

Frequently Asked Questions

How often does AUROBINDO PHARMA LTD have FDA actions?

AUROBINDO PHARMA LTD has 77 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 "ANDA213265-5" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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