RecallHawk

EQUATE LANSOPRAZOLE (LANSOPRAZOLE)

DEXCEL

Summary

FDA approved EQUATE LANSOPRAZOLE (LANSOPRAZOLE) by DEXCEL. NDA (New Drug) approval (Labeling) on 2026-03-11. TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE, ORAL.

Details

Source

Drug Approval

External ID

NDA208025-18

Action Date

2026-03-11

Status

Approved

Category

drug

Product Code

NDA (New Drug)

Product Description

EQUATE LANSOPRAZOLE (generic: LANSOPRAZOLE), TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE, ORAL. Application: NDA208025

Company

Context & Analysis

DEXCEL has 6 FDA actions in our database.

Frequently Asked Questions

How often does DEXCEL have FDA actions?

DEXCEL has 6 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 "NDA208025-18" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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