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PREGNYL (CHORIOGONADOTROPIN ALFA)

ORGANON USA LLC

Summary

FDA approved PREGNYL (CHORIOGONADOTROPIN ALFA) by ORGANON USA LLC. BLA (Biologic) approval (Labeling) on 2023-03-02. INJECTABLE, INJECTION.

Details

Source

Drug Approval

External ID

BLA017692-43

Action Date

2023-03-02

Status

Approved

Category

drug

Product Code

BLA (Biologic)

Product Description

PREGNYL (generic: CHORIOGONADOTROPIN ALFA), INJECTABLE, INJECTION. Application: BLA017692

Context & Analysis

Frequently Asked Questions

How often does ORGANON USA LLC have FDA actions?

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

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "BLA017692-43" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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