RecallHawk

FINGOLIMOD

BIOCON LTD

Summary

FDA approved FINGOLIMOD by BIOCON LTD. ANDA (Generic) approval (Labeling) on 2026-03-12. CAPSULE, ORAL.

Details

Source

Drug Approval

External ID

ANDA207979-11

Action Date

2026-03-12

Status

Approved

Category

drug

Product Code

ANDA (Generic)

Product Description

FINGOLIMOD, CAPSULE, ORAL. Application: ANDA207979

Company

Context & Analysis

Frequently Asked Questions

How often does BIOCON LTD have FDA actions?

This is the only FDA action we have on record for BIOCON LTD in our database.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "ANDA207979-11" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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