NDA 015923

JANSSEN PHARMS

FDA Drug Application

Application #015923

Documents

• Letter: 2007-05-09
• Letter: 2011-08-15
• Letter: 2008-05-14
• Letter: 2009-08-04
• Letter: 2010-12-06
• Letter: 2011-03-07
• Letter: 2015-05-28
• Letter: 2016-05-20
• Label: 2007-05-07
• Label: 2011-08-16
• Label: 2008-08-29
• Label: 2009-08-14
• Label: 2011-03-04
• Label: 2015-05-29
• Label: 2016-05-20
• Letter: 2007-09-25
• Letter: 2008-08-19
• Letter: 2013-05-07
• Label: 2008-06-05
• Label: 2010-12-04
• Review: 2007-07-06
• Label: 2017-02-27
• Letter: 2017-03-02
• Letter: 2017-12-07
• Label: 2017-12-08
• Letter: 2019-03-12
• Label: 2019-03-12
• Letter: 2020-11-18
• Letter: 2020-11-18
• Label: 2020-11-19

Application Sponsors

NDA 015923

JANSSEN PHARMS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 5MG BASE/ML

1

HALDOL

HALOPERIDOL LACTATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1971-05-18	STANDARD
LABELING; Labeling	SUPPL	4	AP	1975-12-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1975-12-03	STANDARD
LABELING; Labeling	SUPPL	9	AP	1978-02-13
LABELING; Labeling	SUPPL	11	AP	1980-02-12
LABELING; Labeling	SUPPL	12	AP	1981-10-02
LABELING; Labeling	SUPPL	13	AP	1979-07-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1980-01-22	STANDARD
LABELING; Labeling	SUPPL	15	AP	1981-01-23
LABELING; Labeling	SUPPL	16	AP	1981-01-23
LABELING; Labeling	SUPPL	18	AP	1981-10-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1982-06-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1981-04-20	STANDARD
LABELING; Labeling	SUPPL	23	AP	1982-09-08
LABELING; Labeling	SUPPL	24	AP	1983-01-31
LABELING; Labeling	SUPPL	27	AP	1983-03-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1984-10-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1986-04-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1987-01-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	1987-01-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	1988-04-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	1988-07-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	1988-02-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	1988-03-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	51	AP	1988-05-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	1988-06-02	STANDARD
LABELING; Labeling	SUPPL	54	AP	1996-08-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	55	AP	1990-02-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	56	AP	1990-02-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	58	AP	1994-06-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	59	AP	1995-01-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	60	AP	1994-12-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	62	AP	1998-04-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	63	AP	1996-05-10	STANDARD
LABELING; Labeling	SUPPL	66	AP	2000-05-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	68	AP	2000-01-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	69	AP	2000-03-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	70	AP	2000-04-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	71	AP	2000-11-07	STANDARD
LABELING; Labeling	SUPPL	72	AP	2002-04-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	73	AP	2002-12-10	STANDARD
LABELING; Labeling	SUPPL	78	AP	2007-05-04	STANDARD
LABELING; Labeling	SUPPL	79	AP	2011-08-12	STANDARD
LABELING; Labeling	SUPPL	80	AP	2007-09-19	STANDARD
LABELING; Labeling	SUPPL	81	AP	2008-05-13	STANDARD
LABELING; Labeling	SUPPL	82	AP	2008-08-14	STANDARD
LABELING; Labeling	SUPPL	84	AP	2009-07-19	901 REQUIRED
LABELING; Labeling	SUPPL	85	AP	2010-12-01	901 REQUIRED
LABELING; Labeling	SUPPL	86	AP	2011-03-01	UNKNOWN
LABELING; Labeling	SUPPL	89	AP	2013-05-06	STANDARD
LABELING; Labeling	SUPPL	91	AP	2015-05-26	STANDARD
LABELING; Labeling	SUPPL	92	AP	2017-12-05	STANDARD
LABELING; Labeling	SUPPL	93	AP	2020-11-17	STANDARD
LABELING; Labeling	SUPPL	94	AP	2016-05-18	STANDARD
LABELING; Labeling	SUPPL	95	AP	2019-03-08	STANDARD
LABELING; Labeling	SUPPL	96	AP	2017-02-23	901 REQUIRED
LABELING; Labeling	SUPPL	98	AP	2020-11-17	STANDARD

Submissions Property Types

SUPPL	8	Null	0
SUPPL	9	Null	14
SUPPL	14	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	29	Null	0
SUPPL	32	Null	0
SUPPL	38	Null	0
SUPPL	40	Null	0
SUPPL	47	Null	0
SUPPL	48	Null	0
SUPPL	49	Null	0
SUPPL	50	Null	0
SUPPL	51	Null	0
SUPPL	52	Null	0
SUPPL	55	Null	0
SUPPL	56	Null	0
SUPPL	58	Null	0
SUPPL	59	Null	0
SUPPL	60	Null	0
SUPPL	62	Null	0
SUPPL	63	Null	0
SUPPL	68	Null	0
SUPPL	69	Null	0
SUPPL	70	Null	0
SUPPL	71	Null	0
SUPPL	73	Null	0
SUPPL	79	Null	7
SUPPL	85	Null	6
SUPPL	86	Null	6
SUPPL	89	Null	7
SUPPL	91	Null	7
SUPPL	92	Null	31
SUPPL	93	Null	15
SUPPL	94	Null	7
SUPPL	95	Null	15
SUPPL	96	Null	6
SUPPL	98	Null	6

TE Codes

001

Prescription

AP

CDER Filings

JANSSEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 15923
            [companyName] => JANSSEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"HALDOL","activeIngredients":"HALOPERIDOL LACTATE","strength":"EQ 5MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"11\/17\/2020","submission":"SUPPL-98","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/015923s093s098,018701s071s076lbl.pdf\"}]","notes":""},{"actionDate":"03\/08\/2019","submission":"SUPPL-95","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/015923s095lbl.pdf\"}]","notes":""},{"actionDate":"12\/05\/2017","submission":"SUPPL-92","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/015923s092lbl.pdf\"}]","notes":""},{"actionDate":"02\/23\/2017","submission":"SUPPL-96","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/015923s096,018701s074lbl.pdf\"}]","notes":""},{"actionDate":"05\/18\/2016","submission":"SUPPL-94","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/015923s094,018701s072lbl.pdf\"}]","notes":""},{"actionDate":"05\/26\/2015","submission":"SUPPL-91","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/015923s091lbl.pdf\"}]","notes":""},{"actionDate":"08\/12\/2011","submission":"SUPPL-79","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/015923s079lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2011","submission":"SUPPL-86","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/015923s086,018701s063lbl.pdf\"}]","notes":""},{"actionDate":"12\/01\/2010","submission":"SUPPL-85","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/015923s085lbl.pdf\"}]","notes":""},{"actionDate":"07\/19\/2009","submission":"SUPPL-84","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/015923s084lbl.pdf\"}]","notes":""},{"actionDate":"08\/14\/2008","submission":"SUPPL-82","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/015923s082,018701s057lbl.pdf\"}]","notes":""},{"actionDate":"05\/13\/2008","submission":"SUPPL-81","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/015923s081,018701s056lbl.pdf\"}]","notes":""},{"actionDate":"05\/04\/2007","submission":"SUPPL-78","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/015923s078,018701s053lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"HALDOL","submission":"HALOPERIDOL LACTATE","actionType":"EQ 5MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-11-17
        )

)