RecallHawk

Summary

FDA approved PONSTEL by AVION PHARMS. NDA (New Drug) approval (Labeling) on 2025-12-31. CAPSULE, ORAL.

Details

Source

Drug Approval

External ID

NDA015034-47

Action Date

2025-12-31

Status

Approved

Category

drug

Product Code

NDA (New Drug)

Product Description

PONSTEL, CAPSULE, ORAL. Application: NDA015034

Context & Analysis

AVION PHARMS has 3 FDA actions in our database.

Frequently Asked Questions

How often does AVION PHARMS have FDA actions?

AVION PHARMS has 3 FDA actions in our database, including 0 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "NDA015034-47" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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