RecallHawk

BUNAVAIL

BDSI

Summary

FDA approved BUNAVAIL by BDSI. NDA (New Drug) approval (REMS) on 2022-12-16. FILM, BUCCAL.

Details

Source

Drug Approval

External ID

NDA205637-25

Action Date

2022-12-16

Status

Approved

Category

drug

Product Code

NDA (New Drug)

Product Description

BUNAVAIL, FILM, BUCCAL. Application: NDA205637

Company

Context & Analysis

BDSI has 2 FDA actions in our database.

Frequently Asked Questions

How often does BDSI have FDA actions?

BDSI has 2 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 "NDA205637-25" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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