RecallHawk

Summary

FDA approved REQUIP XL by GLAXOSMITHKLINE LLC. NDA (New Drug) approval (Labeling) on 2021-07-12. TABLET, EXTENDED RELEASE, ORAL.

Details

Source

Drug Approval

External ID

NDA022008-13

Action Date

2021-07-12

Status

Approved

Category

drug

Product Code

NDA (New Drug)

Product Description

REQUIP XL, TABLET, EXTENDED RELEASE, ORAL. Application: NDA022008

Context & Analysis

GLAXOSMITHKLINE LLC has 10 FDA actions in our database, including 3 recalls.

Frequently Asked Questions

How often does GLAXOSMITHKLINE LLC have FDA actions?

GLAXOSMITHKLINE LLC has 10 FDA actions in our database, including 3 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "NDA022008-13" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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