# NICORETTE
> **NDA018612** · New Drug Application · Sponsor: HALEON US HOLDINGS · Approved 1984-01-13
## Drug
- **FDA Application Number:** NDA018612
- **Application type:** New Drug Application
- **Brand name:** NICORETTE
- **Generic name:** NICOTINE POLACRILEX
- **Active ingredients:** NICOTINE POLACRILEX
- **Dosage form:** GUM, CHEWING
- **Route:** BUCCAL
- **Marketing status:** Over-the-counter
- **Sponsor:** HALEON US HOLDINGS
- **Manufacturer:** Haleon US Holdings LLC
- **First approval:** 1984-01-13
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018612)
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