Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 50MG BASE/ML | 1 | HALDOL | HALOPERIDOL DECANOATE |
| 002 | INJECTABLE;INJECTION | EQ 100MG BASE/ML | 1 | HALDOL | HALOPERIDOL DECANOATE |
FDA Submissions
| TYPE 2; Type 2 - New Active Ingredient | ORIG | 1 | AP | 1986-01-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1986-06-10 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 1987-02-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1987-06-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1987-06-15 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 1987-06-15 | |
| LABELING; Labeling | SUPPL | 7 | AP | 1986-10-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1987-01-28 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 1987-01-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1987-01-28 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 1987-01-28 | |
| LABELING; Labeling | SUPPL | 12 | AP | 1986-11-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1988-08-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1988-08-24 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 1987-09-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1988-06-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1989-01-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1989-01-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1988-10-20 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 1988-10-20 | |
| LABELING; Labeling | SUPPL | 27 | AP | 1989-01-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1997-01-31 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 1997-01-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1989-02-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1989-05-10 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 1989-10-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1990-12-21 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 1993-04-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1994-06-29 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | AP | 1993-04-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1995-05-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 1994-09-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 1996-05-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 1997-09-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 1998-06-23 | STANDARD |
| LABELING; Labeling | SUPPL | 43 | AP | 2000-05-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 45 | AP | 2000-04-13 | STANDARD |
| LABELING; Labeling | SUPPL | 46 | AP | 2002-04-17 | STANDARD |
| LABELING; Labeling | SUPPL | 53 | AP | 2007-05-04 | STANDARD |
| LABELING; Labeling | SUPPL | 54 | AP | 2011-08-12 | STANDARD |
| LABELING; Labeling | SUPPL | 55 | AP | 2007-09-19 | STANDARD |
| LABELING; Labeling | SUPPL | 56 | AP | 2008-05-13 | STANDARD |
| LABELING; Labeling | SUPPL | 57 | AP | 2008-08-14 | STANDARD |
| LABELING; Labeling | SUPPL | 59 | AP | 2009-07-19 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 62 | AP | 2010-12-01 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 63 | AP | 2011-03-01 | STANDARD |
| LABELING; Labeling | SUPPL | 65 | AP | 2013-05-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 67 | AP | 2013-05-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 68 | AP | 2013-06-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 69 | AP | 2013-12-19 | STANDARD |
| LABELING; Labeling | SUPPL | 70 | AP | 2017-12-05 | STANDARD |
| LABELING; Labeling | SUPPL | 71 | AP | 2020-11-17 | STANDARD |
| LABELING; Labeling | SUPPL | 72 | AP | 2016-05-18 | STANDARD |
| LABELING; Labeling | SUPPL | 73 | AP | 2019-03-08 | STANDARD |
| LABELING; Labeling | SUPPL | 74 | AP | 2017-02-23 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 76 | AP | 2020-11-17 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 41 | Null | 0 |
| SUPPL | 45 | Null | 0 |
| SUPPL | 54 | Null | 15 |
| SUPPL | 62 | Null | 7 |
| SUPPL | 63 | Null | 6 |
| SUPPL | 65 | Null | 15 |
| SUPPL | 67 | Null | 0 |
| SUPPL | 68 | Null | 0 |
| SUPPL | 69 | Null | 0 |
| SUPPL | 70 | Null | 15 |
| SUPPL | 71 | Null | 6 |
| SUPPL | 72 | Null | 7 |
| SUPPL | 73 | Null | 15 |
| SUPPL | 74 | Null | 6 |
| SUPPL | 76 | Null | 6 |
TE Codes
| 001 | Prescription | AO |
| 002 | Prescription | AO |
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 18701
[companyName] => JANSSEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"HALDOL","activeIngredients":"HALOPERIDOL DECANOATE","strength":"EQ 50MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"HALDOL","activeIngredients":"HALOPERIDOL DECANOATE","strength":"EQ 100MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"11\/17\/2020","submission":"SUPPL-76","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-73","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/018701s073lbl.pdf\"}]","notes":""},{"actionDate":"12\/05\/2017","submission":"SUPPL-70","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/018701s070lbl.pdf\"}]","notes":""},{"actionDate":"02\/23\/2017","submission":"SUPPL-74","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-72","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/015923s094,018701s072lbl.pdf\"}]","notes":""},{"actionDate":"08\/12\/2011","submission":"SUPPL-54","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/018701s054lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2011","submission":"SUPPL-63","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-62","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/018701s062lbl.pdf\"}]","notes":""},{"actionDate":"07\/19\/2009","submission":"SUPPL-59","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/018701s059lbl.pdf\"}]","notes":""},{"actionDate":"08\/14\/2008","submission":"SUPPL-57","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-56","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-53","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 DECANOATE","actionType":"EQ 50MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"HALDOL","submission":"HALOPERIDOL DECANOATE","actionType":"EQ 100MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-11-17
)
)