RecallHawk

Summary

FDA approved ZILEUTON by ANNORA PHARMA. ANDA (Generic) approval on 2022-10-11. TABLET, EXTENDED RELEASE, ORAL.

Details

Source

Drug Approval

External ID

ANDA215742-1

Action Date

2022-10-11

Status

Approved

Category

drug

Product Code

ANDA (Generic)

Product Description

ZILEUTON, TABLET, EXTENDED RELEASE, ORAL. Application: ANDA215742

Context & Analysis

ANNORA PHARMA has 22 FDA actions in our database.

Frequently Asked Questions

How often does ANNORA PHARMA have FDA actions?

ANNORA PHARMA has 22 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 "ANDA215742-1" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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