FDA — authorised 22 March 1996
- Application: NDA020385
- Marketing authorisation holder: PFIZER INC
- Local brand name: NICOTROL
- Indication: SPRAY, METERED — NASAL
- Status: approved
🇺🇸 Placebo Tablet and Nicotine Patch in United States
FDA authorised Placebo Tablet and Nicotine Patch on 22 March 1996
Marketing authorisations
FDA — authorised 3 July 1996
- Application: NDA020536
- Marketing authorisation holder: MCNEIL CONS
- Local brand name: NICOTROL
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA — authorised 2 May 1997
- Application: NDA020714
- Marketing authorisation holder: PFIZER
- Local brand name: NICOTROL
- Indication: INHALANT — ORAL
- Status: approved
FDA
- Status: approved
Placebo Tablet and Nicotine Patch 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 Placebo Tablet and Nicotine Patch approved in United States?
Yes. FDA authorised it on 22 March 1996; FDA authorised it on 3 July 1996; FDA authorised it on 2 May 1997.
Who is the marketing authorisation holder for Placebo Tablet and Nicotine Patch in United States?
PFIZER INC holds the US marketing authorisation.