Documents
Application Sponsors
Marketing Status
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
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
)
)