FDA Approved Products

Application #	Type	Sponsor	Product #	Drug Name	Form	Strength	Active Ingredient	Approval Date	Marketing Status	Reference Standard
219683	NDA	JANSSEN BIOTECH	001	INLEXZO	SYSTEM;INTRAVESICAL	EQ 250MG BASE	GEMCITABINE HYDROCHLORIDE	2025-09-09	Prescription	Yes
761430	BLA	JANSSEN BIOTECH	001	IMAAVY	INJECTABLE;INJECTION	300MG/1.62ML(185MG/ML)	NIPOCALIMAB-AAHU	2025-04-29	Prescription	No
761430	BLA	JANSSEN BIOTECH	002	IMAAVY	INJECTABLE;INJECTION	1200MG/6.5ML(185MG/ML)	NIPOCALIMAB-AAHU	2025-04-29	Prescription	No
219008	NDA	JANSSEN BIOTECH	001	LAZCLUZE	TABLET;ORAL	EQ 80MG BASE	LAZERTINIB MESYLATE	2024-08-19	Prescription	No
219008	NDA	JANSSEN BIOTECH	002	LAZCLUZE	TABLET;ORAL	EQ 240MG BASE	LAZERTINIB MESYLATE	2024-08-19	Prescription	Yes
219016	NDA	JANSSEN PRODS	001	EDURANT PED	TABLET, FOR SUSPENSION;ORAL	EQ 2.5MG BASE	RILPIVIRINE HYDROCHLORIDE	2024-03-15	Prescription	Yes
216793	NDA	JANSSEN BIOTECH	001	AKEEGA	TABLET;ORAL	500MG;EQ 50MG BASE	ABIRATERONE ACETATE; NIRAPARIB TOSYLATE	2023-08-11	Prescription	No
216793	NDA	JANSSEN BIOTECH	002	AKEEGA	TABLET;ORAL	500MG;EQ 100MG BASE	ABIRATERONE ACETATE; NIRAPARIB TOSYLATE	2023-08-11	Prescription	Yes
761342	BLA	JANSSEN BIOTECH	001	TALVEY	INJECTABLE;INJECTION	3MG/1.5ML(2MG/ML)	TALQUETAMAB-TGVS	2023-08-09	Prescription	No
761342	BLA	JANSSEN BIOTECH	002	TALVEY	INJECTABLE;INJECTION	40MG/ML	TALQUETAMAB-TGVS	2023-08-09	Prescription	No
761291	BLA	JANSSEN BIOTECH	001	TECVAYLI	INJECTABLE;INJECTION	30MG/3ML(10MG/ML)	TECLISTAMAB-CQYV	2022-10-25	Prescription	No
761291	BLA	JANSSEN BIOTECH	002	TECVAYLI	INJECTABLE;INJECTION	153MG/1.7ML(90MG/ML)	TECLISTAMAB-CQYV	2022-10-25	Prescription	No
215859	NDA	JANSSEN PHARMS	001	XARELTO	FOR SUSPENSION;ORAL	1MG/ML	RIVAROXABAN	2021-12-20	Prescription	Yes
761210	BLA	JANSSEN BIOTECH	001	RYBREVANT	INJECTABLE;INJECTION	350MG/7ML(50MG/ML)	AMIVANTAMAB-VMJW	2021-05-21	Prescription	No
761145	BLA	JANSSEN BIOTECH	001	DARZALEX FASPRO	INJECTABLE;INJECTION	120MG;2000UNITS/ML	DARATUMUMAB AND HYALURONIDASE-FIHJ	2020-05-01	Prescription	No
212018	NDA	JANSSEN BIOTECH	001	BALVERSA	TABLET;ORAL	3MG	ERDAFITINIB	2019-04-12	Prescription	No
			002	BALVERSA	TABLET;ORAL	4MG	ERDAFITINIB	2019-04-12	Prescription	No
			003	BALVERSA	TABLET;ORAL	5MG	ERDAFITINIB	2019-04-12	Prescription	Yes
211243	NDA	JANSSEN PHARMS	001	SPRAVATO	SPRAY;NASAL	EQ 28MG BASE	ESKETAMINE HYDROCHLORIDE	2019-03-05	Prescription	Yes
210455	NDA	JANSSEN PRODS	001	SYMTUZA	TABLET;ORAL	150MG;800MG;200MG;EQ 10MG BASE	COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	2018-07-17	Prescription	Yes
210951	NDA	JANSSEN BIOTECH	001	ERLEADA	TABLET;ORAL	60MG	APALUTAMIDE	2018-02-14	Prescription	No
210951	NDA	JANSSEN BIOTECH	002	ERLEADA	TABLET;ORAL	240MG	APALUTAMIDE	2018-02-14	Prescription	Yes
761061	BLA	JANSSEN BIOTECH	001	TREMFYA	INJECTABLE;INJECTION	100MG/ML	GUSELKUMAB	2017-07-13	Prescription	No
208398	NDA	JANSSEN PHARMS	001	VERMOX	TABLET, CHEWABLE;ORAL	500MG	MEBENDAZOLE	2016-10-19	Discontinued	No
761044	BLA	JANSSEN BIOTECH	001	STELARA	INJECTABLE;INJECTION	130MG/26ML	USTEKINUMAB	2016-09-23	Prescription	No
205879	NDA	JANSSEN PHARMS	001	INVOKAMET XR	TABLET, EXTENDED RELEASE;ORAL	50MG;500MG	CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE	2016-09-20	Prescription	No
			002	INVOKAMET XR	TABLET, EXTENDED RELEASE;ORAL	50MG;1GM	CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE	2016-09-20	Prescription	No
			003	INVOKAMET XR	TABLET, EXTENDED RELEASE;ORAL	150MG;500MG	CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE	2016-09-20	Prescription	No
			004	INVOKAMET XR	TABLET, EXTENDED RELEASE;ORAL	150MG;1GM	CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE	2016-09-20	Prescription	Yes
761036	BLA	JANSSEN BIOTECH	001	DARZALEX	INJECTABLE;INJECTION	100MG/5ML	DARATUMUMAB	2015-11-16	Prescription	No
761036	BLA	JANSSEN BIOTECH	002	DARZALEX	INJECTABLE;INJECTION	400MG/20ML	DARATUMUMAB	2015-11-16	Prescription	No
207953	NDA	JANSSEN PRODS	001	YONDELIS	POWDER;INTRAVENOUS	1MG/VIAL	TRABECTEDIN	2015-10-23	Prescription	Yes
207946	NDA	JANSSEN PHARMS	005	INVEGA HAFYERA	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	1.092GM/3.5ML (312MG/ML)	PALIPERIDONE PALMITATE	2015-05-18	Prescription	No
			006	INVEGA HAFYERA	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	1.560GM/5ML (312MG/ML)	PALIPERIDONE PALMITATE	2015-05-18	Prescription	No
			001	INVEGA TRINZA	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	273MG/0.875ML (273MG/0.875ML)	PALIPERIDONE PALMITATE	2015-05-18	Prescription	Yes
			002	INVEGA TRINZA	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	410MG/1.315ML (311.79MG/ML)	PALIPERIDONE PALMITATE	2015-05-18	Prescription	Yes
			003	INVEGA TRINZA	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	546MG/1.75ML (312MG/ML)	PALIPERIDONE PALMITATE	2015-05-18	Prescription	Yes
			004	INVEGA TRINZA	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	819MG/2.625ML (312MG/ML)	PALIPERIDONE PALMITATE	2015-05-18	Prescription	Yes
205395	NDA	JANSSEN PRODS	001	PREZCOBIX	TABLET;ORAL	150MG;EQ 800MG BASE	COBICISTAT; DARUNAVIR ETHANOLATE	2015-01-29	Prescription	Yes
205395	NDA	JANSSEN PRODS	002	PREZCOBIX	TABLET;ORAL	150MG;EQ 675MG BASE	COBICISTAT; DARUNAVIR ETHANOLATE	2015-01-29	Prescription	No
204353	NDA	JANSSEN PHARMS	001	INVOKAMET	TABLET;ORAL	50MG;500MG	CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE	2014-08-08	Prescription	No
			002	INVOKAMET	TABLET;ORAL	50MG;1GM	CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE	2014-08-08	Prescription	No
			003	INVOKAMET	TABLET;ORAL	150MG;500MG	CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE	2014-08-08	Prescription	No
			004	INVOKAMET	TABLET;ORAL	150MG;1GM	CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE	2014-08-08	Prescription	Yes
205123	NDA	JANSSEN PRODS	001	OLYSIO	CAPSULE;ORAL	EQ 150MG BASE	SIMEPREVIR SODIUM	2013-11-22	Discontinued	No
125433	BLA	JANSSEN BIOTECH	001	SIMPONI ARIA	INJECTABLE; INJECTION	50MG/4ML	GOLIMUMAB	2013-07-18	Prescription	No
204042	NDA	JANSSEN PHARMS	001	INVOKANA	TABLET;ORAL	100MG	CANAGLIFLOZIN	2013-03-29	Prescription	No
204042	NDA	JANSSEN PHARMS	002	INVOKANA	TABLET;ORAL	300MG	CANAGLIFLOZIN	2013-03-29	Prescription	Yes
204384	NDA	JANSSEN THERAP	001	SIRTURO	TABLET;ORAL	EQ 100MG BASE	BEDAQUILINE FUMARATE	2012-12-28	Prescription	Yes
204384	NDA	JANSSEN THERAP	002	SIRTURO	TABLET;ORAL	EQ 20MG BASE	BEDAQUILINE FUMARATE	2012-12-28	Prescription	No
202895	NDA	JANSSEN PRODS	001	PREZISTA	SUSPENSION;ORAL	100MG/ML	DARUNAVIR	2011-12-16	Prescription	Yes
202439	NDA	JANSSEN PHARMS	001	XARELTO	TABLET;ORAL	10MG	RIVAROXABAN	2011-11-04	Prescription	No
			002	XARELTO	TABLET;ORAL	15MG	RIVAROXABAN	2011-11-04	Prescription	No
			003	XARELTO	TABLET;ORAL	20MG	RIVAROXABAN	2011-11-04	Prescription	No
			004	XARELTO	TABLET;ORAL	2.5MG	RIVAROXABAN	2011-11-04	Prescription	No
022406	NDA	JANSSEN PHARMS	001	XARELTO	TABLET;ORAL	10MG	RIVAROXABAN	2011-07-01	Prescription	No
			002	XARELTO	TABLET;ORAL	15MG	RIVAROXABAN	2011-07-01	Prescription	No
			003	XARELTO	TABLET;ORAL	20MG	RIVAROXABAN	2011-07-01	Prescription	Yes
			004	XARELTO	TABLET;ORAL	2.5MG	RIVAROXABAN	2011-07-01	Prescription	No
202022	NDA	JANSSEN PRODS	001	EDURANT	TABLET;ORAL	EQ 25MG BASE	RILPIVIRINE HYDROCHLORIDE	2011-05-20	Prescription	Yes
202379	NDA	JANSSEN BIOTECH	001	ZYTIGA	TABLET;ORAL	250MG	ABIRATERONE ACETATE	2011-04-28	Prescription	No
202379	NDA	JANSSEN BIOTECH	002	ZYTIGA	TABLET;ORAL	500MG	ABIRATERONE ACETATE	2011-04-28	Prescription	Yes
022264	NDA	JANSSEN PHARMS	001	INVEGA SUSTENNA	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	39MG/0.25ML (39MG/0.25ML)	PALIPERIDONE PALMITATE	2009-07-31	Prescription	No
			002	INVEGA SUSTENNA	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	78MG/0.5ML (78MG/0.5ML)	PALIPERIDONE PALMITATE	2009-07-31	Prescription	No
			003	INVEGA SUSTENNA	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	117MG/0.75ML (117MG/0.75ML)	PALIPERIDONE PALMITATE	2009-07-31	Prescription	No
			004	INVEGA SUSTENNA	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	156MG/ML (156MG/ML)	PALIPERIDONE PALMITATE	2009-07-31	Prescription	Yes
			005	INVEGA SUSTENNA	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	234MG/1.5ML (156MG/ML)	PALIPERIDONE PALMITATE	2009-07-31	Prescription	No
022187	NDA	JANSSEN R AND D	001	INTELENCE	TABLET;ORAL	100MG	ETRAVIRINE	2008-01-18	Prescription	No
			002	INTELENCE	TABLET;ORAL	200MG	ETRAVIRINE	2008-01-18	Prescription	Yes
			003	INTELENCE	TABLET;ORAL	25MG	ETRAVIRINE	2008-01-18	Prescription	No
022043	NDA	JANSSEN LP	001	INVEGA	TABLET, EXTENDED RELEASE; ORAL	3MG	PALIPERIDONE	2007-04-27	Prescription	No
			002	INVEGA	TABLET, EXTENDED RELEASE; ORAL	6MG	PALIPERIDONE	2007-04-27	Prescription	No
			003	INVEGA	TABLET, EXTENDED RELEASE; ORAL	9MG	PALIPERIDONE	2007-04-27	Prescription	No
			004	INVEGA	TABLET, EXTENDED RELEASE; ORAL	12MG	PALIPERIDONE	2007-04-27	Prescription	No
021999	NDA	JANSSEN PHARMS	001	INVEGA	TABLET, EXTENDED RELEASE;ORAL	3MG	PALIPERIDONE	2006-12-19	Prescription	No
			002	INVEGA	TABLET, EXTENDED RELEASE;ORAL	6MG	PALIPERIDONE	2006-12-19	Prescription	Yes
			003	INVEGA	TABLET, EXTENDED RELEASE;ORAL	9MG	PALIPERIDONE	2006-12-19	Prescription	No
			004	INVEGA	TABLET, EXTENDED RELEASE;ORAL	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PALIPERIDONE	2006-12-19	Discontinued	No
			006	INVEGA	TABLET, EXTENDED RELEASE;ORAL	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PALIPERIDONE	2006-12-19	Discontinued	No
021976	NDA	JANSSEN PRODS	001	PREZISTA	TABLET;ORAL	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	DARUNAVIR	2006-06-23	Discontinued	No
			002	PREZISTA	TABLET;ORAL	600MG	DARUNAVIR	2006-06-23	Prescription	No
			003	PREZISTA	TABLET;ORAL	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	DARUNAVIR	2006-06-23	Discontinued	No
			004	PREZISTA	TABLET;ORAL	75MG	DARUNAVIR	2006-06-23	Prescription	No
			005	PREZISTA	TABLET;ORAL	150MG	DARUNAVIR	2006-06-23	Prescription	No
			006	PREZISTA	TABLET;ORAL	800MG	DARUNAVIR	2006-06-23	Prescription	Yes
021615	NDA	JANSSEN PHARMS	001	RAZADYNE ER	CAPSULE, EXTENDED RELEASE;ORAL	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GALANTAMINE HYDROBROMIDE	2005-04-01	Discontinued	No
			002	RAZADYNE ER	CAPSULE, EXTENDED RELEASE;ORAL	EQ 16MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GALANTAMINE HYDROBROMIDE	2005-04-01	Discontinued	No
			003	RAZADYNE ER	CAPSULE, EXTENDED RELEASE;ORAL	EQ 24MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GALANTAMINE HYDROBROMIDE	2005-04-01	Discontinued	No
021721	NDA	JANSSEN PHARMS	001	LEVAQUIN	SOLUTION;ORAL	250MG/10ML	LEVOFLOXACIN	2004-10-21	Discontinued	No
021346	NDA	JANSSEN PHARMS	001	RISPERDAL CONSTA	INJECTABLE;INTRAMUSCULAR	25MG/VIAL	RISPERIDONE	2003-10-29	Prescription	Yes
			002	RISPERDAL CONSTA	INJECTABLE;INTRAMUSCULAR	37.5MG/VIAL	RISPERIDONE	2003-10-29	Prescription	No
			003	RISPERDAL CONSTA	INJECTABLE;INTRAMUSCULAR	50MG/VIAL	RISPERIDONE	2003-10-29	Prescription	No
			004	RISPERDAL CONSTA	INJECTABLE;INTRAMUSCULAR	12.5MG/VIAL	RISPERIDONE	2003-10-29	Prescription	No
021444	NDA	JANSSEN PHARMS	001	RISPERDAL	TABLET, ORALLY DISINTEGRATING;ORAL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	RISPERIDONE	2003-04-02	Discontinued	No
			002	RISPERDAL	TABLET, ORALLY DISINTEGRATING;ORAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	RISPERIDONE	2003-04-02	Discontinued	No
			003	RISPERDAL	TABLET, ORALLY DISINTEGRATING;ORAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	RISPERIDONE	2003-04-02	Discontinued	No
			004	RISPERDAL	TABLET, ORALLY DISINTEGRATING;ORAL	3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	RISPERIDONE	2003-04-02	Discontinued	No
			005	RISPERDAL	TABLET, ORALLY DISINTEGRATING;ORAL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	RISPERIDONE	2003-04-02	Discontinued	No
021241	NDA	JANSSEN PHARMS	001	ORTHO TRI-CYCLEN LO	TABLET;ORAL-28	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ETHINYL ESTRADIOL; NORGESTIMATE	2002-08-22	Discontinued	No
021180	NDA	JANSSEN PHARMS	001	ORTHO EVRA	FILM, EXTENDED RELEASE;TRANSDERMAL	0.035MG/24HR;0.15MG/24HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ETHINYL ESTRADIOL; NORELGESTROMIN	2001-11-20	Discontinued	No
021123	NDA	JANSSEN PHARMS	001	ULTRACET	TABLET;ORAL	325MG;37.5MG	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	2001-08-15	Discontinued	No
021224	NDA	JANSSEN PHARMS	001	RAZADYNE	SOLUTION;ORAL	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GALANTAMINE HYDROBROMIDE	2001-06-22	Discontinued	No
021001	NDA	JANSSEN PHARMS	001	AXERT	TABLET;ORAL	EQ 6.25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ALMOTRIPTAN MALATE	2001-05-07	Discontinued	No
021001	NDA	JANSSEN PHARMS	002	AXERT	TABLET;ORAL	EQ 12.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ALMOTRIPTAN MALATE	2001-05-07	Discontinued	No
021169	NDA	JANSSEN PHARMS	001	RAZADYNE	TABLET;ORAL	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GALANTAMINE HYDROBROMIDE	2001-02-28	Discontinued	No
			002	RAZADYNE	TABLET;ORAL	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GALANTAMINE HYDROBROMIDE	2001-02-28	Discontinued	No
			003	RAZADYNE	TABLET;ORAL	EQ 12MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GALANTAMINE HYDROBROMIDE	2001-02-28	Discontinued	No
021121	NDA	JANSSEN PHARMS	001	CONCERTA	TABLET, EXTENDED RELEASE;ORAL	18MG	METHYLPHENIDATE HYDROCHLORIDE	2000-08-01	Prescription	No
			002	CONCERTA	TABLET, EXTENDED RELEASE;ORAL	36MG	METHYLPHENIDATE HYDROCHLORIDE	2000-08-01	Prescription	No
			003	CONCERTA	TABLET, EXTENDED RELEASE;ORAL	54MG	METHYLPHENIDATE HYDROCHLORIDE	2000-08-01	Prescription	Yes
			004	CONCERTA	TABLET, EXTENDED RELEASE;ORAL	27MG	METHYLPHENIDATE HYDROCHLORIDE	2000-08-01	Prescription	No
021088	NDA	ORTHO MCNEIL JANSSEN	001	VIADUR	IMPLANT;IMPLANTATION	EQ 65MG BASE	LEUPROLIDE ACETATE	2000-03-03	Discontinued	No
020966	NDA	JANSSEN PHARMS	001	SPORANOX	INJECTABLE;INJECTION	10MG/ML	ITRACONAZOLE	1999-03-30	Discontinued	No
020897	NDA	JANSSEN PHARMS	001	DITROPAN XL	TABLET, EXTENDED RELEASE;ORAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OXYBUTYNIN CHLORIDE	1998-12-16	Discontinued	No
			002	DITROPAN XL	TABLET, EXTENDED RELEASE;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OXYBUTYNIN CHLORIDE	1998-12-16	Discontinued	No
			003	DITROPAN XL	TABLET, EXTENDED RELEASE;ORAL	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OXYBUTYNIN CHLORIDE	1998-12-16	Discontinued	No
020844	NDA	JANSSEN PHARMS	001	TOPAMAX	CAPSULE;ORAL	15MG	TOPIRAMATE	1998-10-26	Prescription	No
			002	TOPAMAX	CAPSULE;ORAL	25MG	TOPIRAMATE	1998-10-26	Prescription	Yes
			003	TOPAMAX SPRINKLE	CAPSULE;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TOPIRAMATE	1998-10-26	Discontinued	No
020767	NDA	JANSSEN PHARMA	001	PROPULSID QUICKSOLV	TABLET, ORALLY DISINTEGRATING;ORAL	EQ 20MG BASE	CISAPRIDE MONOHYDRATE	1997-11-07	Discontinued	No
020657	NDA	JANSSEN PHARMS	001	SPORANOX	SOLUTION;ORAL	10MG/ML	ITRACONAZOLE	1997-02-21	Discontinued	No
020505	NDA	JANSSEN PHARMS	001	TOPAMAX	TABLET;ORAL	100MG	TOPIRAMATE	1996-12-24	Prescription	Yes
			002	TOPAMAX	TABLET;ORAL	200MG	TOPIRAMATE	1996-12-24	Prescription	No
			003	TOPAMAX	TABLET;ORAL	300MG	TOPIRAMATE	1996-12-24	Discontinued	No
			004	TOPAMAX	TABLET;ORAL	25MG	TOPIRAMATE	1996-12-24	Prescription	No
			005	TOPAMAX	TABLET;ORAL	50MG	TOPIRAMATE	1996-12-24	Prescription	No
			006	TOPAMAX	TABLET;ORAL	400MG	TOPIRAMATE	1996-12-24	Discontinued	No
020634	NDA	JANSSEN PHARMS	001	LEVAQUIN	TABLET;ORAL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LEVOFLOXACIN	1996-12-20	Discontinued	No
			002	LEVAQUIN	TABLET;ORAL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LEVOFLOXACIN	1996-12-20	Discontinued	No
			003	LEVAQUIN	TABLET;ORAL	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LEVOFLOXACIN	1996-12-20	Discontinued	No
020635	NDA	JANSSEN PHARMS	001	LEVAQUIN	INJECTABLE;INJECTION	EQ 500MG/20ML (EQ 25MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LEVOFLOXACIN	1996-12-20	Discontinued	No
			004	LEVAQUIN	INJECTABLE;INJECTION	EQ 750MG/30ML (EQ 25MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LEVOFLOXACIN	1996-12-20	Discontinued	No
			002	LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER	INJECTABLE;INJECTION	EQ 250MG/50ML (EQ 5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LEVOFLOXACIN	1996-12-20	Discontinued	No
			003	LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER	INJECTABLE;INJECTION	EQ 500MG/100ML (EQ 5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LEVOFLOXACIN	1996-12-20	Discontinued	No
			005	LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER	INJECTABLE;INJECTION	EQ 750MG/150ML (EQ 5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LEVOFLOXACIN	1996-12-20	Discontinued	No
020694	NDA	JANSSEN PHARMA	001	SPORANOX	CAPSULE; ORAL	100MG	ITRACONAZOLE	1996-12-06	Prescription	No
020193	NDA	JANSSEN PHARMS	001	ELMIRON	CAPSULE;ORAL	100MG	PENTOSAN POLYSULFATE SODIUM	1996-09-26	Prescription	Yes
020588	NDA	JANSSEN PHARMS	001	RISPERDAL	SOLUTION;ORAL	1MG/ML	RISPERIDONE	1996-06-10	Prescription	Yes
020398	NDA	JANSSEN PHARMS	001	PROPULSID	SUSPENSION;ORAL	EQ 1MG BASE/ML	CISAPRIDE MONOHYDRATE	1995-09-15	Discontinued	No
020281	NDA	JANSSEN PHARMS	001	ULTRAM	TABLET;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TRAMADOL HYDROCHLORIDE	1995-03-03	Discontinued	No
020281	NDA	JANSSEN PHARMS	002	ULTRAM	TABLET;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TRAMADOL HYDROCHLORIDE	1995-03-03	Discontinued	No
020272	NDA	JANSSEN PHARMS	001	RISPERDAL	TABLET;ORAL	1MG	RISPERIDONE	1993-12-29	Prescription	Yes
			002	RISPERDAL	TABLET;ORAL	2MG	RISPERIDONE	1993-12-29	Prescription	No
			003	RISPERDAL	TABLET;ORAL	3MG	RISPERIDONE	1993-12-29	Prescription	No
			004	RISPERDAL	TABLET;ORAL	4MG	RISPERIDONE	1993-12-29	Prescription	No
			005	RISPERDAL	TABLET;ORAL	5MG	RISPERIDONE	1993-12-29	Discontinued	No
			007	RISPERDAL	TABLET;ORAL	0.5MG	RISPERIDONE	1993-12-29	Prescription	No
			008	RISPERDAL	TABLET;ORAL	0.25MG	RISPERIDONE	1993-12-29	Prescription	No
020210	NDA	JANSSEN PHARMS	001	PROPULSID	TABLET;ORAL	EQ 10MG BASE	CISAPRIDE MONOHYDRATE	1993-07-29	Discontinued	No
020210	NDA	JANSSEN PHARMS	002	PROPULSID	TABLET;ORAL	EQ 20MG BASE	CISAPRIDE MONOHYDRATE	1993-07-29	Discontinued	No
020229	NDA	JANSSEN PHARMS	001	LEUSTATIN	INJECTABLE;INJECTION	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CLADRIBINE	1993-02-26	Discontinued	No
020301	NDA	JANSSEN PHARMS	001	ORTHO-CEPT	TABLET;ORAL-21	0.15MG;0.03MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	DESOGESTREL; ETHINYL ESTRADIOL	1992-12-14	Discontinued	No
020301	NDA	JANSSEN PHARMS	002	ORTHO-CEPT	TABLET;ORAL-28	0.15MG;0.03MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	DESOGESTREL; ETHINYL ESTRADIOL	1992-12-14	Discontinued	No
020083	NDA	JANSSEN PHARMS	001	SPORANOX	CAPSULE;ORAL	100MG	ITRACONAZOLE	1992-09-11	Prescription	Yes
019697	NDA	JANSSEN PHARMS	001	ORTHO TRI-CYCLEN	TABLET;ORAL-28	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ETHINYL ESTRADIOL; NORGESTIMATE	1992-07-03	Discontinued	No
019697	NDA	JANSSEN PHARMS	002	ORTHO TRI-CYCLEN	TABLET;ORAL-21	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ETHINYL ESTRADIOL; NORGESTIMATE	1992-07-03	Discontinued	No
019964	NDA	JANSSEN PHARMS	001	TERAZOL 3	CREAM;VAGINAL	0.8% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TERCONAZOLE	1991-02-21	Discontinued	No
019735	NDA	JANSSEN PHARMS	001	FLOXIN	TABLET;ORAL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OFLOXACIN	1990-12-28	Discontinued	No
			002	FLOXIN	TABLET;ORAL	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OFLOXACIN	1990-12-28	Discontinued	No
			003	FLOXIN	TABLET;ORAL	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OFLOXACIN	1990-12-28	Discontinued	No
019002	NDA	JOHNSON AND JOHNSON	001	VASCOR	TABLET;ORAL	200MG	BEPRIDIL HYDROCHLORIDE	1990-12-28	Discontinued	No
			002	VASCOR	TABLET;ORAL	300MG	BEPRIDIL HYDROCHLORIDE	1990-12-28	Discontinued	No
			003	VASCOR	TABLET;ORAL	400MG	BEPRIDIL HYDROCHLORIDE	1990-12-28	Discontinued	No
019927	NDA	JANSSEN PHARMS	001	NIZORAL	SHAMPOO;TOPICAL	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	KETOCONAZOLE	1990-08-31	Discontinued	No
019813	NDA	JANSSEN PHARMS	001	DURAGESIC-100	FILM, EXTENDED RELEASE;TRANSDERMAL	100MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FENTANYL	1990-08-07	Discontinued	No
			005	DURAGESIC-12	FILM, EXTENDED RELEASE;TRANSDERMAL	12.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FENTANYL	1990-08-07	Discontinued	No
			004	DURAGESIC-25	FILM, EXTENDED RELEASE;TRANSDERMAL	25MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FENTANYL	1990-08-07	Discontinued	No
			006	DURAGESIC-37	FILM, EXTENDED RELEASE;TRANSDERMAL	37.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FENTANYL	1990-08-07	Discontinued	No
			003	DURAGESIC-50	FILM, EXTENDED RELEASE;TRANSDERMAL	50MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FENTANYL	1990-08-07	Discontinued	No
			002	DURAGESIC-75	FILM, EXTENDED RELEASE;TRANSDERMAL	75MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FENTANYL	1990-08-07	Discontinued	No
020035	NDA	JANSSEN PHARMA	001	ERGAMISOL	TABLET;ORAL	EQ 50MG BASE	LEVAMISOLE HYDROCHLORIDE	1990-06-18	Discontinued	No
019653	NDA	JANSSEN PHARMS	001	ORTHO CYCLEN-21	TABLET;ORAL-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ETHINYL ESTRADIOL; NORGESTIMATE	1989-12-29	Discontinued	No
019653	NDA	JANSSEN PHARMS	002	ORTHO CYCLEN-28	TABLET;ORAL-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ETHINYL ESTRADIOL; NORGESTIMATE	1989-12-29	Discontinued	No
019641	NDA	JANSSEN PHARMS	001	TERAZOL 3	SUPPOSITORY;VAGINAL	80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TERCONAZOLE	1988-05-24	Discontinued	No
019579	NDA	JANSSEN PHARMS	001	TERAZOL 7	CREAM;VAGINAL	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TERCONAZOLE	1987-12-31	Discontinued	No
018701	NDA	JANSSEN PHARMS	001	HALDOL	INJECTABLE;INJECTION	EQ 50MG BASE/ML	HALOPERIDOL DECANOATE	1986-01-14	Prescription	Yes
018701	NDA	JANSSEN PHARMS	002	HALDOL	INJECTABLE;INJECTION	EQ 100MG BASE/ML	HALOPERIDOL DECANOATE	1986-01-14	Prescription	Yes
019084	NDA	JANSSEN PHARMA	001	NIZORAL	CREAM;TOPICAL	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	KETOCONAZOLE	1985-12-31	Discontinued	No
050594	NDA	JOHNSON AND JOHNSON	001	ERYCETTE	SWAB;TOPICAL	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ERYTHROMYCIN	1985-02-15	Discontinued	No
088790	ANDA	JANSSEN PHARMS	001	TYLOX	CAPSULE;ORAL	500MG;5MG	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	1984-12-12	Discontinued	No
019037	NDA	JANSSEN PHARMS	001	IMODIUM	SOLUTION;ORAL	1MG/5ML	LOPERAMIDE HYDROCHLORIDE	1984-07-31	Discontinued	No
018985	NDA	JANSSEN PHARMS	001	ORTHO-NOVUM 7/7/7-21	TABLET;ORAL-21	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	ETHINYL ESTRADIOL; NORETHINDRONE	1984-04-04	Discontinued	No
018985	NDA	JANSSEN PHARMS	002	ORTHO-NOVUM 7/7/7-28	TABLET;ORAL-28	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ETHINYL ESTRADIOL; NORETHINDRONE	1984-04-04	Discontinued	No
018354	NDA	ORTHO MCNEIL JANSSEN	001	ORTHO-NOVUM 10/11-21	TABLET;ORAL-21	0.035MG,0.035MG;0.5MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ETHINYL ESTRADIOL; NORETHINDRONE	1982-01-11	Discontinued	No
018354	NDA	ORTHO MCNEIL JANSSEN	002	ORTHO-NOVUM 10/11-28	TABLET;ORAL-28	0.035MG,0.035MG;0.5MG,1MG	ETHINYL ESTRADIOL; NORETHINDRONE	1982-01-11	Discontinued	No
018533	NDA	JANSSEN PHARMS	001	NIZORAL	TABLET;ORAL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	KETOCONAZOLE	1981-06-12	Discontinued	No
018211	NDA	ORTHO MCNEIL JANSSEN	001	DITROPAN	SYRUP;ORAL	5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OXYBUTYNIN CHLORIDE	1979-11-29	Discontinued	No
018084	NDA	ORTHO MCNEIL JANSSEN	001	TOLECTIN DS	CAPSULE;ORAL	EQ 400MG BASE	TOLMETIN SODIUM	1979-10-30	Discontinued	No
018040	NDA	JANSSEN PHARMA	001	MONISTAT	INJECTABLE;INJECTION	10MG/ML	MICONAZOLE	1978-10-04	Discontinued	No
017821	NDA	JANSSEN RES AND DEV	001	FLEXERIL	TABLET;ORAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CYCLOBENZAPRINE HYDROCHLORIDE	1977-08-26	Discontinued	No
017821	NDA	JANSSEN RES AND DEV	002	FLEXERIL	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CYCLOBENZAPRINE HYDROCHLORIDE	1977-08-26	Discontinued	No
085055	ANDA	JANSSEN PHARMS	001	TYLENOL W/ CODEINE NO. 1	TABLET;ORAL	300MG;7.5MG	ACETAMINOPHEN; CODEINE PHOSPHATE	1977-08-17	Discontinued	No
			002	TYLENOL W/ CODEINE NO. 2	TABLET;ORAL	300MG;15MG	ACETAMINOPHEN; CODEINE PHOSPHATE	1977-08-17	Discontinued	No
			003	TYLENOL W/ CODEINE NO. 3	TABLET;ORAL	300MG;30MG	ACETAMINOPHEN; CODEINE PHOSPHATE	1977-08-17	Discontinued	No
			004	TYLENOL W/ CODEINE NO. 4	TABLET;ORAL	300MG;60MG	ACETAMINOPHEN; CODEINE PHOSPHATE	1977-08-17	Discontinued	No
017919	NDA	JANSSEN PHARMS	002	ORTHO-NOVUM 1/35-28	TABLET;ORAL-28	0.035MG;1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ETHINYL ESTRADIOL; NORETHINDRONE	1977-06-23	Discontinued	No
017735	NDA	JANSSEN PHARMS	001	MODICON 28	TABLET;ORAL-28	0.035MG;0.5MG	ETHINYL ESTRADIOL; NORETHINDRONE	1976-05-14	Discontinued	No
017628	NDA	ORTHO MCNEIL JANSSEN	001	TOLECTIN	TABLET;ORAL	EQ 200MG BASE	TOLMETIN SODIUM	1976-03-24	Discontinued	No
017628	NDA	ORTHO MCNEIL JANSSEN	002	TOLECTIN 600	TABLET;ORAL	EQ 600MG BASE	TOLMETIN SODIUM	1976-03-24	Discontinued	No
017577	NDA	JANSSEN PHARMS	001	DITROPAN	TABLET;ORAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OXYBUTYNIN CHLORIDE	1975-07-16	Discontinued	No
017481	NDA	JANSSEN PHARMS	001	VERMOX	TABLET, CHEWABLE;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	MEBENDAZOLE	1974-06-28	Discontinued	No
016954	NDA	JANSSEN PHARMS	001	MICRONOR	TABLET;ORAL-28	0.35MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	NORETHINDRONE	1973-01-02	Discontinued	No
050448	NDA	JOHNSON AND JOHNSON	001	GRIFULVIN V	SUSPENSION;ORAL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GRISEOFULVIN, MICROCRYSTALLINE	1972-05-30	Discontinued	No
015923	NDA	JANSSEN PHARMS	001	HALDOL	INJECTABLE;INJECTION	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	HALOPERIDOL LACTATE	1971-05-18	Discontinued	No
016769	NDA	ORTHO MCNEIL JANSSEN	001	URISPAS	TABLET;ORAL	100MG	FLAVOXATE HYDROCHLORIDE	1970-01-15	Discontinued	No
070767	ANDA	JANSSEN PHARMA	001	NIZORAL	SUSPENSION;ORAL	100MG/5ML	KETOCONAZOLE		Discontinued	No
050518	NDA	JOHNSON AND JOHNSON	001	MECLAN	CREAM;TOPICAL	1%	MECLOCYCLINE SULFOSALICYLATE		Discontinued	No
016709	NDA	ORTHO MCNEIL JANSSEN	001	ORTHO-NOVUM 1/50 28	TABLET;ORAL-28	0.05MG;1MG	MESTRANOL; NORETHINDRONE	1968-08-21	Discontinued	No
011529	NDA	JANSSEN R AND D	002	PARAFON FORTE DSC	TABLET;ORAL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CHLORZOXAZONE	1958-08-15	Discontinued	No