RecallHawk

ENJAYMO (SUTIMLIMAB-JOME)

RECORDATI RARE DISEASES, INC.

Summary

FDA approved ENJAYMO (SUTIMLIMAB-JOME) by RECORDATI RARE DISEASES, INC.. BLA (Biologic) approval (Labeling) on 2024-02-08. INJECTABLE, INJECTION.

Details

Source

Drug Approval

External ID

BLA761164-4

Action Date

2024-02-08

Status

Approved

Category

drug

Product Code

BLA (Biologic)

Product Description

ENJAYMO (generic: SUTIMLIMAB-JOME), INJECTABLE, INJECTION. Application: BLA761164

Context & Analysis

RECORDATI RARE DISEASES, INC. has 2 FDA actions in our database, including 1 recall.

Frequently Asked Questions

How often does RECORDATI RARE DISEASES, INC. have FDA actions?

RECORDATI RARE DISEASES, INC. has 2 FDA actions in our database, including 1 recall and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "BLA761164-4" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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