FDA Approved Products

Application #	Type	Sponsor	Product #	Drug Name	Form	Strength	Active Ingredient	Approval Date	Marketing Status	Reference Standard
211733	NDA	HALEON US HOLDINGS	001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	TABLET;ORAL	250MG;125MG	ACETAMINOPHEN; IBUPROFEN	2020-02-28	Over-the-counter	Yes
205434	NDA	HALEON US HOLDINGS	001	FLONASE ALLERGY RELIEF	SPRAY, METERED;NASAL	0.05MG/SPRAY	FLUTICASONE PROPIONATE	2014-07-23	Over-the-counter	No
201803	NDA	HALEON US HOLDINGS	001	ADVIL	TABLET;ORAL	EQ 200MG BASE	IBUPROFEN SODIUM	2012-06-12	Over-the-counter	Yes
022113	NDA	HALEON US HOLDINGS	001	ADVIL ALLERGY AND CONGESTION RELIEF	TABLET;ORAL	4MG;200MG;10MG	CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE	2011-12-21	Over-the-counter	Yes
022113	NDA	HALEON US HOLDINGS	002	ADVIL MULTI-SYMPTOM COLD & FLU	TABLET;ORAL	4MG;200MG;10MG	CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE	2011-12-21	Over-the-counter	Yes
022565	NDA	HALEON US HOLDINGS	001	ADVIL CONGESTION RELIEF	TABLET;ORAL	200MG;10MG	IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE	2010-05-27	Over-the-counter	Yes
022360	NDA	HALEON US HOLDINGS	001	NICORETTE	TROCHE/LOZENGE;ORAL	EQ 2MG BASE	NICOTINE POLACRILEX	2009-05-18	Over-the-counter	No
022360	NDA	HALEON US HOLDINGS	002	NICORETTE	TROCHE/LOZENGE;ORAL	EQ 4MG BASE	NICOTINE POLACRILEX	2009-05-18	Over-the-counter	Yes
022122	NDA	HALEON US HOLDINGS	001	VOLTAREN ARTHRITIS PAIN	GEL;TOPICAL	1%	DICLOFENAC SODIUM	2007-10-17	Over-the-counter	Yes
022051	NDA	HALEON US HOLDINGS	002	FLONASE SENSIMIST ALLERGY RELIEF	SPRAY, METERED;NASAL	0.0275MG/SPRAY	FLUTICASONE FUROATE	2007-04-27	Over-the-counter	Yes
021887	NDA	HALEON US HOLDINGS	001	ALLI	CAPSULE;ORAL	60MG	ORLISTAT	2007-02-07	Over-the-counter	Yes
021393	NDA	HALEON US HOLDINGS	001	ADVIL PM	CAPSULE;ORAL	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN	2005-12-21	Over-the-counter	Yes
021394	NDA	HALEON US HOLDINGS	001	ADVIL PM	TABLET;ORAL	38MG;200MG	DIPHENHYDRAMINE CITRATE; IBUPROFEN	2005-12-21	Over-the-counter	Yes
021587	NDA	HALEON US HOLDINGS	001	CHILDREN'S ADVIL ALLERGY SINUS	SUSPENSION;ORAL	1MG/5ML;100MG/5ML;15MG/5ML	CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	2004-02-24	Over-the-counter	Yes
021441	NDA	HALEON US HOLDINGS	001	ADVIL ALLERGY SINUS	TABLET;ORAL	2MG;200MG;30MG	CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	2002-12-19	Over-the-counter	Yes
021330	NDA	HALEON US HOLDINGS	001	NICORETTE	TROCHE/LOZENGE;ORAL	EQ 2MG BASE	NICOTINE POLACRILEX	2002-10-31	Over-the-counter	No
021330	NDA	HALEON US HOLDINGS	002	NICORETTE	TROCHE/LOZENGE;ORAL	EQ 4MG BASE	NICOTINE POLACRILEX	2002-10-31	Over-the-counter	Yes
021374	NDA	HALEON US HOLDINGS	001	ADVIL COLD AND SINUS	CAPSULE;ORAL	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	2002-05-30	Over-the-counter	Yes
021373	NDA	HALEON US HOLDINGS	001	CHILDREN'S ADVIL COLD	SUSPENSION;ORAL	100MG/5ML;15MG/5ML	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	2002-04-18	Over-the-counter	No
020941	NDA	HALEON US HOLDINGS	001	ABREVA	CREAM;TOPICAL	10%	DOCOSANOL	2000-07-25	Over-the-counter	Yes
020944	NDA	HALEON US HOLDINGS	001	CHILDREN'S ADVIL	TABLET, CHEWABLE;ORAL	50MG	IBUPROFEN	1998-12-18	Over-the-counter	No
020944	NDA	HALEON US HOLDINGS	002	JUNIOR STRENGTH ADVIL	TABLET, CHEWABLE;ORAL	100MG	IBUPROFEN	1998-12-18	Over-the-counter	No
020812	NDA	HALEON US HOLDINGS	002	INFANT'S ADVIL	SUSPENSION/DROPS;ORAL	50MG/1.25ML	IBUPROFEN	1998-01-30	Over-the-counter	Yes
020812	NDA	HALEON US HOLDINGS	001	PEDIATRIC ADVIL	SUSPENSION/DROPS;ORAL	100MG/2.5ML	IBUPROFEN	1998-01-30	Discontinued	No
020802	NDA	HALEON US HOLDINGS	001	EXCEDRIN (MIGRAINE RELIEF)	TABLET;ORAL	250MG;250MG;65MG	ACETAMINOPHEN; ASPIRIN; CAFFEINE	1998-01-14	Over-the-counter	Yes
020267	NDA	HALEON US HOLDINGS	002	JUNIOR STRENGTH ADVIL	TABLET;ORAL	100MG	IBUPROFEN	1996-12-13	Over-the-counter	No
020589	NDA	HALEON US HOLDINGS	001	CHILDREN'S ADVIL	SUSPENSION;ORAL	100MG/5ML	IBUPROFEN	1996-06-27	Over-the-counter	No
020589	NDA	HALEON US HOLDINGS	002	CHILDREN'S ADVIL-FLAVORED	SUSPENSION;ORAL	100MG/5ML	IBUPROFEN	1996-06-27	Over-the-counter	No
020555	NDA	HALEON US HOLDINGS	001	AXID AR	TABLET;ORAL	75MG	NIZATIDINE	1996-05-09	Over-the-counter	Yes
020402	NDA	HALEON US HOLDINGS	001	ADVIL LIQUI-GELS	CAPSULE;ORAL	EQ 200MG FREE ACID AND POTASSIUM SALT	IBUPROFEN	1995-04-20	Over-the-counter	Yes
020402	NDA	HALEON US HOLDINGS	002	ADVIL MIGRAINE LIQUI-GELS	CAPSULE;ORAL	EQ 200MG FREE ACID AND POTASSIUM SALT	IBUPROFEN	1995-04-20	Over-the-counter	Yes
020121	NDA	HALEON US HOLDINGS	001	FLONASE	SPRAY, METERED;NASAL	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FLUTICASONE PROPIONATE	1994-10-19	Discontinued	No
020925	NDA	HALEON US HOLDINGS	001	TAVIST-1	TABLET;ORAL	1.34MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CLEMASTINE FUMARATE	1992-08-21	Discontinued	No
020066	NDA	HALEON US HOLDINGS	002	NICORETTE	GUM, CHEWING;BUCCAL	EQ 4MG BASE	NICOTINE POLACRILEX	1992-06-08	Over-the-counter	Yes
			004	NICORETTE	GUM, CHEWING;BUCCAL	EQ 4MG BASE	NICOTINE POLACRILEX	1992-06-08	Over-the-counter	No
			003	NICORETTE (MINT)	GUM, CHEWING;BUCCAL	EQ 4MG BASE	NICOTINE POLACRILEX	1992-06-08	Over-the-counter	No
019771	NDA	HALEON US HOLDINGS	001	ADVIL COLD AND SINUS	TABLET;ORAL	200MG;30MG	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	1989-09-19	Over-the-counter	Yes
019833	NDA	HALEON US HOLDINGS	002	CHILDREN'S ADVIL	SUSPENSION;ORAL	100MG/5ML	IBUPROFEN	1989-09-19	Discontinued	No
018989	NDA	HALEON US HOLDINGS	001	ADVIL	TABLET;ORAL	200MG	IBUPROFEN	1984-05-18	Over-the-counter	Yes
018612	NDA	HALEON US HOLDINGS	002	NICORETTE	GUM, CHEWING;BUCCAL	EQ 2MG BASE	NICOTINE POLACRILEX	1984-01-13	Over-the-counter	No
			004	NICORETTE	GUM, CHEWING;BUCCAL	EQ 2MG BASE	NICOTINE POLACRILEX	1984-01-13	Over-the-counter	No
			003	NICORETTE (MINT)	GUM, CHEWING;BUCCAL	EQ 2MG BASE	NICOTINE POLACRILEX	1984-01-13	Over-the-counter	No