Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022360
Company: HALEON US HOLDINGS

• Summary Review

Products on NDA 22360

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NICORETTE	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE;ORAL	Over-the-counter	None	Yes	No
NICORETTE	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE;ORAL	Over-the-counter	None	Yes	Yes

Labels for NDA 022360

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/17/2025	SUPPL-19	Manufacturing (CMC)-Formulation	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022360Orig1s019lbl.pdf
11/21/2024	SUPPL-18	Manufacturing (CMC)-Formulation	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022360Orig1s018lbl.pdf
04/30/2024	SUPPL-17	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022360Orig1s017lbl.pdf
03/05/2021	SUPPL-12	Manufacturing (CMC)-Formulation	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022360Orig1s012lbl.pdf
06/05/2018	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022360ORig1s011lbl.pdf
09/30/2015	SUPPL-10	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022360s010lbl.pdf
04/16/2015	SUPPL-9	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022360Orig1s009lbl.pdf
10/28/2013	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022360Orig1s007lbl.pdf
05/23/2013	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022360Orig1s006lbl.pdf
09/18/2012	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022360Orig1s004lbl.pdf