Data updated: Mar 10, 2026
NICOTINE POLACRILEX
NICOTINE POLACRILEX
Approved 1999-03-15
31
Indications
--
Phase 3 Trials
26
Years on Market
Details
- Status
- Over-the-counter
- First Approved
- 1999-03-15
- Routes
- BUCCAL, ORAL
- Dosage Forms
- GUM, CHEWING, TROCHE/LOZENGE
Companies
PERRIGO R AND D P AND L PPI-DAC IVAX SUB TEVA PHARMS PLD ACQUISITIONS Dr. Reddy's Aurobindo Pharma L PERRIGO CO FERTIN PHARMA
Active Ingredient: NICOTINE POLACRILEX
Website: ↗
NICOTINE POLACRILEX Approval History
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What NICOTINE POLACRILEX Treats
31 FDA approvalsOriginally approved for its first indication in 1999 . Covers 31 distinct patient populations.
- Other (31)
Other
(31 approvals)- • Approved indication (Mar 1999)Label Letter
- • Approved indication (Mar 1999)Label Letter
- • Approved indication (Jul 2004)Letter
- • Approved indication (Sep 2004)
- • Approved indication (Jan 2006)Letter
- • Approved indication (Oct 2006)
- • Approved indication (May 2007)
- • Approved indication (Apr 2008)
- • Approved indication (Dec 2008)
- • Approved indication (Feb 2009)
- • Approved indication (Jul 2009)
- • Approved indication (Jul 2009)
- • Approved indication (Jul 2011)
- • Approved indication (Oct 2012)
- • Approved indication (Feb 2016)Letter
- • Approved indication (May 2016)
- • Approved indication (Dec 2016)
- • Approved indication (Jun 2018)Letter
- • Approved indication (Jul 2018)
- • Approved indication (Feb 2019)
- • Approved indication (Jul 2019)
- • Approved indication (Sep 2019)
- • Approved indication (Oct 2019)Letter
- • Approved indication (Jan 2020)
- • Approved indication (Feb 2020)
- • Approved indication (May 2020)
- • Approved indication (Aug 2020)
- • Approved indication (Aug 2021)
- • Approved indication (May 2022)
- • Approved indication (Dec 2022)
- • Approved indication (Jul 2025) New
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NICOTINE POLACRILEX FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.