FDA — authorised 13 January 1984
- Application: NDA018612
- Marketing authorisation holder: HALEON US HOLDINGS
- Local brand name: NICORETTE
- Indication: GUM, CHEWING — BUCCAL
- Status: approved
🇺🇸 Nicotine Gum in United States
FDA authorised Nicotine Gum on 13 January 1984
Marketing authorisations
FDA — authorised 8 June 1992
- Application: NDA020066
- Marketing authorisation holder: HALEON US HOLDINGS
- Local brand name: NICORETTE
- Indication: GUM, CHEWING — BUCCAL
- Status: approved
FDA — authorised 18 May 2009
- Application: NDA022360
- Marketing authorisation holder: HALEON US HOLDINGS
- Local brand name: NICORETTE
- Indication: TROCHE/LOZENGE — ORAL
- Status: approved
FDA
- Status: approved
Nicotine Gum in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Nicotine Gum approved in United States?
Yes. FDA authorised it on 13 January 1984; FDA authorised it on 8 June 1992; FDA authorised it on 18 May 2009.
Who is the marketing authorisation holder for Nicotine Gum in United States?
HALEON US HOLDINGS holds the US marketing authorisation.