FDA — authorised 13 January 1984
- Application: NDA018612
- Marketing authorisation holder: HALEON US HOLDINGS
- Local brand name: NICORETTE
- Indication: GUM, CHEWING — BUCCAL
- Status: approved
🇺🇸 Nicotine Lozenge in United States
FDA authorised Nicotine Lozenge on 13 January 1984
Marketing authorisations
FDA — authorised 31 January 2006
- Application: ANDA077007
- Marketing authorisation holder: PERRIGO R AND D
- Status: supplemented
FDA
- Status: approved
Nicotine Lozenge 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 Lozenge approved in United States?
Yes. FDA authorised it on 13 January 1984; FDA authorised it on 31 January 2006; FDA has authorised it.
Who is the marketing authorisation holder for Nicotine Lozenge in United States?
HALEON US HOLDINGS holds the US marketing authorisation.