RecallHawk

NICOTINE POLACRILEX

P AND L

Summary

FDA approved NICOTINE POLACRILEX by P AND L. ANDA (Generic) approval (Labeling) on 2026-02-05. GUM, CHEWING, BUCCAL.

Details

Source

Drug Approval

External ID

ANDA079216-15

Action Date

2026-02-05

Status

Approved

Category

drug

Product Code

ANDA (Generic)

Product Description

NICOTINE POLACRILEX, GUM, CHEWING, BUCCAL. Application: ANDA079216

Company

Context & Analysis

P AND L has 2 FDA actions in our database.

Frequently Asked Questions

How often does P AND L have FDA actions?

P AND L 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 "ANDA079216-15" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

Want to know the moment something like this happens?

Get alerts for drug

Related Actions