NICOTINE POLACRILEX | A076568 | P AND L DEVELOPMENT LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Nico Worldwide, L.L.C. FDA-2004-P-0482 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 | Open | Nico Worldwide |
Citizen Petition from Nico Worldwide, L.L.C. FDA-2004-P-0419 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 | Open | Nico Worldwide |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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