NICOTROL
Details
- Status
- Prescription
- First Approved
- 1996-03-22
- Routes
- NASAL, TRANSDERMAL, ORAL
- Dosage Forms
- SPRAY, METERED, FILM, EXTENDED RELEASE, INHALANT
NICOTROL Approval History
What NICOTROL Treats
1 indicationsNICOTROL is approved for 1 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Nicotine Withdrawal
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
NICOTROL FDA Label Details
ProIndications & Usage
FDA Label (PDF)NICOTROL NS is indicated as an aid to smoking cessation for the relief of nicotine withdrawal symptoms. NICOTROL NS therapy should be used as a part of a comprehensive behavioral smoking cessation program. The safety and efficacy of the continued use of NICOTROL NS for periods longer than 6 months have not been adequately studied and such use is not recommended.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.