NICOTINE POLACRILEX | N020066 | HALEON US HOLDINGS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizens Petition from McKenna and Cuneo LLP on behalf of McKenna & Cuneo FDA-1995-P-0238 McKenna & Cuneo LLP, on behalf of a pharmaceutical client, filed this citizen petition pursuant to section 701 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA Commissioner refrain from granting three years of market exclusivity to Nicorette and Nicorette DS (nicotine polacrilex g | Other | 2012-07-10 | Open | McKenna & Cuneo |
Citizen Petition from Nico Worldwide, L.L.C. FDA-2004-P-0482 · 5 docket documents Nico Worldwide, LLC filed this ANDA suitability petition on July 2, 2004, requesting authorization under 21 CFR 314.93 and Section 505(j)(2)(C) to submit an ANDA for Nicotine Bitartrate oral solution in 2 mg base per 240 mL and 4 mg base per 240 mL strengths, which would differ from the reference li | Other | 2010-11-24 | Denied | Nico Worldwide, L.L.C. |
Citizen Petition from Nico Worldwide, L.L.C. FDA-2004-P-0419 · 5 docket documents Nico Worldwide, LLC filed this ANDA Suitability Petition under section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 CFR 314.93 requesting authorization to submit an Abbreviated New Drug Application for Nicotine Base oral solution at 2 mg base per 240 mL and 4 mg base per 240 mL, wh | Other | 2010-11-04 | Denied | Nico Worldwide, L.L.C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8323683 | Apr 30, 2028 | — | — | Yes | — | — |