FDA — authorised 13 January 1984
- Application: NDA018612
- Marketing authorisation holder: HALEON US HOLDINGS
- Indication: Type 1 - New Molecular Entity
- Status: approved
🇺🇸 Nicorette in United States
FDA authorised Nicorette on 13 January 1984
Marketing authorisations
FDA — authorised 7 November 1991
- Marketing authorisation holder: SANOFI AVENTIS US
- Status: approved
FDA — authorised 28 January 2013
- Application: ANDA078697
- Marketing authorisation holder: P AND L
- Indication: Labeling
- Status: approved
FDA — authorised 28 January 2013
- Application: ANDA078699
- Marketing authorisation holder: P AND L
- Indication: Labeling
- Status: approved
FDA — authorised 5 June 2018
- Application: NDA022360
- Marketing authorisation holder: HALEON US HOLDINGS
- Indication: Labeling
- Status: approved
FDA — authorised 15 December 2020
- Application: ANDA212983
- Marketing authorisation holder: DR REDDYS LABS SA
- Indication: Labeling
- Status: approved
Nicorette in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Nicorette approved in United States?
Yes. FDA authorised it on 13 January 1984; FDA authorised it on 7 November 1991; FDA authorised it on 28 January 2013.
Who is the marketing authorisation holder for Nicorette in United States?
HALEON US HOLDINGS holds the US marketing authorisation.