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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018612
Company: HALEON US HOLDINGS

Products on NDA 18612

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NICORETTE	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING;BUCCAL	Over-the-counter	None	Yes	No
NICORETTE	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING;BUCCAL	Over-the-counter	None	Yes	No
NICORETTE (MINT)	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING;BUCCAL	Over-the-counter	None	Yes	No

Labels for NDA 018612

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/03/2024	SUPPL-84	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018612Orig1s084;020066Orig1s066lbl.pdf
04/23/2021	SUPPL-83	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018612Orig1s083,020066Orig1s065lbl.pdf
11/14/2018	SUPPL-81	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020066Orig1s062,018612Orig1s081lbl.pdf
06/05/2018	SUPPL-80	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020066Orig1s061,018612Orig1s080lbl.pdf
09/11/2017	SUPPL-78	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018612s078,020066s059lbl.pdf
09/30/2015	SUPPL-76	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018612s076lbl.pdf
10/30/2014	SUPPL-74	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s074, 020066Orig1s055lbl.pdf
06/11/2014	SUPPL-73	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s072, s073, 020066Orig1s053, s054lbl .pdf
06/11/2014	SUPPL-72	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s072, s073, 020066Orig1s053, s054lbl .pdf
10/30/2013	SUPPL-68	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018612Orig1s068,020066Orig1s049lbl.pdf
07/16/2012	SUPPL-65	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018612Orig1s065, 020066Orig1s046lbl.pdf
02/15/2012	SUPPL-61	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018612s061_020066s042lbl.pdf
06/26/2007	SUPPL-49	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018612s049,02066s030lbl.pdf
06/26/2007	SUPPL-49	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018612s049,02066s030lbl.pdf
12/02/2005	SUPPL-42	Manufacturing (CMC)-Formulation	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018612s042,020066s023lbl.pdf
12/23/1998	SUPPL-25	Efficacy-Accelerated Approval Confirmatory Study	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18-612S025_Nicorette_prntlbl.pdf

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