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Summary

FDA approved RISVAN by LABS FARMS ROVI SA. NDA (New Drug) approval (Labeling) on 2025-01-22. FOR SUSPENSION, EXTENDED RELEASE, INTRAMUSCULAR.

Details

Source

Drug Approval

External ID

NDA214835-4

Action Date

2025-01-22

Status

Approved

Category

drug

Product Code

NDA (New Drug)

Product Description

RISVAN, FOR SUSPENSION, EXTENDED RELEASE, INTRAMUSCULAR. Application: NDA214835

Context & Analysis

Frequently Asked Questions

How often does LABS FARMS ROVI SA have FDA actions?

This is the only FDA action we have on record for LABS FARMS ROVI SA in our database.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "NDA214835-4" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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