RecallHawk

BREXAFEMME

GLAXOSMITHKLINE

Summary

FDA approved BREXAFEMME by GLAXOSMITHKLINE. NDA (New Drug) approval (Labeling) on 2025-11-03. TABLET, ORAL.

Details

Source

Drug Approval

External ID

NDA214900-3

Action Date

2025-11-03

Status

Approved

Category

drug

Product Code

NDA (New Drug)

Product Description

BREXAFEMME, TABLET, ORAL. Application: NDA214900

Context & Analysis

GLAXOSMITHKLINE has 15 FDA actions in our database.

Frequently Asked Questions

How often does GLAXOSMITHKLINE have FDA actions?

GLAXOSMITHKLINE has 15 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 "NDA214900-3" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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