Nicotine

Clinical Trials

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Title	Posted	Study ID	Phase	Status	Sponsor
Evaluating the Impact of Quitting Using Executive Function Strategy Training (QUEST) on Smoking Cessation in Homeless Young Adult Smokers	2024/12/20	NCT06745154	Not Applicable	Completed	Ohio State University Comprehensive Cancer Center
Compensatory Behavior of E-cig Users in Response to Reduced Nicotine E-liquids	2024/09/19	NCT06602492	Not Applicable	Completed	Rochester Institute of Technology
The Options 2 Study	2024/09/19	NCT06595459	Phase 4	Recruiting	University of Wisconsin, Madison
Rural Smoking Cessation	2024/09/05	NCT06584929	Not Applicable	Not yet recruiting	Masonic Cancer Center, University of Minnesota
Adaptive Use of Nicotine Substitution to Maintain Smoking Reduction/Abstinence in Nicotine Responders	2024/08/15	NCT06554873	Phase 3	Active, not recruiting	Rose Research Center, LLC
C-Raven, a Virtual Tobacco Cessation Intervention in the Community	2024/08/09	NCT06545669	Phase 4	Recruiting	Johns Hopkins University
Transcranial Magnetic Stimulation for Nicotine Dependence: An Effectiveness-Implementation Trial	2024/08/02	NCT06534047	Phase 4	Not yet recruiting	Centre for Addiction and Mental Health
The Avenues Study: Dual Use Cessation	2024/06/25	NCT06474299	Phase 4	Recruiting	University of Wisconsin, Madison
Evaluating the Delivery and Effects of THC Vaping Liquids in the Bloodstream	2024/03/27	NCT06334016	Early Phase 1	Not yet recruiting	Roswell Park Cancer Institute
Informing Oral Nicotine Pouch Regulations to Promote Public Health	2024/03/18	NCT06315881	Phase 2	Recruiting	Ohio State University Comprehensive Cancer Center

FDA Drug Approvals

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Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Nicotine Mini	Rite Aid Corporation	11822-3315	ORAL	2 mg in 1 1	8/20/2025
Nicotine Polacrilex	Bryant Ranch Prepack	72162-2266	ORAL	2 mg in 1 1	8/26/2025
NICOTINE	Walgreen Company	0363-7269	ORAL	2 mg in 1 1	2/27/2025
Nicotine Polacrilex	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	55910-976	ORAL	4 mg in 1 1	1/29/2025
Nicotine	P & L Development, LLC	59726-913	ORAL	4 mg in 1 1	9/9/2025
Nicotine Polacrilex	Lucy Goods, Inc.	72224-927	ORAL	2 mg in 1 1	4/28/2025
Nicotine Polacrilex	Lucy Goods, Inc.	72224-933	ORAL	4 mg in 1 1	4/29/2025
Nicotine	Meijer Distribution Inc	41250-456	ORAL	2 mg in 1 1	2/18/2025
Nicotine Polacrilex coated cinnamon	CVS Pharmacy	69842-028	BUCCAL	4 mg in 1 1	8/1/2025
Nicotine transdermal system	Target Corporation	11673-194	TRANSDERMAL	21 mg in 24 h	6/10/2025

EMA Drug Approvals

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Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
NICOTINELL MINT 2mg CHEWING-GUM	FERTIN PHARMA A/S (7100)	SIN12569P	GUM, CHEWING	2 mg	7/27/2004
Nicorette Icy Mint Medicated Chewing Gum 2mg	McNeil AB	SIN14326P	GUM, CHEWING	2mg	3/12/2013
NICOTINELL MINT LOZENGE 1 mg	Swissco Services AG	SIN11732P	LOZENGE	1 mg	11/27/2001
Nicorette Invisi Transdermal Patch 10mg/16 hours	LTS Lohmann Therapie-Systeme AG	SIN14294P	PATCH, EXTENDED RELEASE	15.75 mg/9 sq cm	1/17/2013
SKIIP NICOTINE MINI LOZENGE 2 MG (Cinnamon)	Rubicon Research Private Limited	SIN17062P	LOZENGE	2.00 mg	8/14/2024
SKIIP NICOTINE MINI LOZENGE 2 MG (CHERRY)	Rubicon Research Private Limited	SIN17060P	LOZENGE	2.00 mg	8/14/2024
SKIIP NICOTINE MINI LOZENGE 4 MG (Cherry)	Rubicon Research Private Limited	SIN17061P	LOZENGE	4.00 mg	8/14/2024
SKIIP NICOTINE MINI LOZENGE 4 MG (Cinnamon)	Rubicon Research Private Limited	SIN17063P	LOZENGE	4.00 mg	8/14/2024

NMPA Drug Approvals

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Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
HERRON NICAWAY STEP 2 PATCH Nicotine 35mg transdermal nicotine patch sachet	324940	Perrigo Australia Pty Ltd	Medicine	A	10/16/2019
NICORETTE nicotine 4mg (as nicotine polacrilex) freshfruit flavour chewing gum blister pack	142472	Johnson & Johnson Pacific Pty Ltd	Medicine	A	7/24/2007
NICORETTE FRESHDROPS nicotine 2mg lozenge blister pack	188136	Johnson & Johnson Pacific Pty Ltd	Medicine	A	8/18/2011
NICORETTE nicotine 4 mg (as nicotine polacrilex) icy mint flavour chewing gum blister pack	165908	Johnson & Johnson Pacific Pty Ltd	Medicine	A	10/7/2009
NICORETTE nicotine 2mg (as nicotine polacrilex) classic flavour chewing gum blister pack	12515	Johnson & Johnson Pacific Pty Ltd	Medicine	A	8/13/1991
NICOTINELL PEPPERMINT LOZENGES nicotine (as nicotine polacrilex) 4 mg lozenge blister pack	276926	Perrigo Australia Pty Ltd	Medicine	A	6/23/2016
NICORETTE FRUITDROPS nicotine 2 mg (as nicotine polacrilex) lozenge carton	489226	Johnson & Johnson Pacific Pty Ltd	Medicine	A	5/19/2025
HERRON NICAWAY LOZENGES, nicotine 4 mg (as nicotine polacrilex) lozenge blister pack	170630	Perrigo Australia Pty Ltd	Medicine	A	4/16/2010
NICABATE CLEAR PATCH nicotine 14mg/24 hours transdermal drug delivery system sachet	81034	Haleon Australia Pty Ltd	Medicine	A	12/7/2001
AMCAL STEP 2 NICOTINE PATCHES 14 MG/24 HOURS nicotine 35mg transdermal drug delivery system sachet	228122	Perrigo Australia Pty Ltd	Medicine	A	9/17/2014

Health Canada Drug Approvals

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Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

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Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
NICOTINELL 7 MG/24 HORAS PARCHE TRANSDERMICOS	Haleon Spain S.A.	68302	PARCHE TRANSDÉRMICO	Sin Receta	Commercialized
NICOTINELL 21 MG/24 HORAS PARCHE TRANSDERMICO	Haleon Spain S.A.	68303	PARCHE TRANSDÉRMICO	Sin Receta	Commercialized
NICOTINELL FRUIT 4 mg CHICLE MEDICAMENTOSO	Haleon Spain S.A.	65586	CHICLE MEDICAMENTOSO	Sin Receta	Commercialized
NIQUITIN CLEAR 7 MG/24 H PARCHES TRANSDERMICOS	Perrigo Espana S.A.	65840	PARCHE TRANSDÉRMICO	Sin Receta	Commercialized
NIQUITIN CLEAR 21 MG/24 HORAS PARCHE TRANSDERMICO	Perrigo Espana S.A.	65842	PARCHE TRANSDÉRMICO	Sin Receta	Commercialized

Philippines FDA Drug Approvals

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Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

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Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

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Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

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