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LUTATHERA (LUTETIUM LU 177 DOTATATE)

AAA USA INC

Summary

FDA approved LUTATHERA (LUTETIUM LU 177 DOTATATE) by AAA USA INC. NDA (New Drug) approval (Labeling) on 2024-11-26. SOLUTION, INTRAVENOUS.

Details

Source

Drug Approval

External ID

NDA208700-32

Action Date

2024-11-26

Status

Approved

Category

drug

Product Code

NDA (New Drug)

Product Description

LUTATHERA (generic: LUTETIUM LU 177 DOTATATE), SOLUTION, INTRAVENOUS. Application: NDA208700

Context & Analysis

Frequently Asked Questions

How often does AAA USA INC have FDA actions?

This is the only FDA action we have on record for AAA USA INC in our database.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "NDA208700-32" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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