FDA — authorised 29 December 2008
- Application: ANDA078699
- Marketing authorisation holder: P AND L
- Status: supplemented
🇺🇸 Nicotine Polacrilex Gum (2 mg) in United States
FDA authorised Nicotine Polacrilex Gum (2 mg) on 29 December 2008
Marketing authorisations
FDA — authorised 8 July 2009
- Application: ANDA079044
- Marketing authorisation holder: P AND L
- Status: supplemented
Other Smoking Cessation / Addiction Medicine approved in United States
Frequently asked questions
Is Nicotine Polacrilex Gum (2 mg) approved in United States?
Yes. FDA authorised it on 29 December 2008; FDA authorised it on 8 July 2009.
Who is the marketing authorisation holder for Nicotine Polacrilex Gum (2 mg) in United States?
P AND L holds the US marketing authorisation.