Documents
Application Sponsors
Marketing Status
Application Products
001 | TABLET;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | NIZORAL | KETOCONAZOLE |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1981-06-12 | PRIORITY |
LABELING; Labeling | SUPPL | 2 | AP | 1983-06-23 | PRIORITY |
LABELING; Labeling | SUPPL | 3 | AP | 1986-06-30 | PRIORITY |
LABELING; Labeling | SUPPL | 4 | AP | 1983-06-23 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1983-04-15 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1983-04-15 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1983-09-08 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1984-07-09 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1984-07-09 | PRIORITY |
LABELING; Labeling | SUPPL | 11 | AP | 1986-06-30 | PRIORITY |
LABELING; Labeling | SUPPL | 12 | AP | 1986-06-30 | PRIORITY |
LABELING; Labeling | SUPPL | 13 | AP | 1986-06-30 | PRIORITY |
LABELING; Labeling | SUPPL | 14 | AP | 1986-06-30 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1985-06-19 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1988-05-10 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1988-07-08 | PRIORITY |
LABELING; Labeling | SUPPL | 18 | AP | 1989-04-14 | PRIORITY |
LABELING; Labeling | SUPPL | 19 | AP | 1991-03-15 | PRIORITY |
LABELING; Labeling | SUPPL | 20 | AP | 1992-12-28 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1992-10-13 | PRIORITY |
LABELING; Labeling | SUPPL | 22 | AP | 1992-12-28 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1993-09-20 | PRIORITY |
LABELING; Labeling | SUPPL | 24 | AP | 1994-03-22 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1995-09-08 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1995-09-08 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1995-09-15 | PRIORITY |
LABELING; Labeling | SUPPL | 29 | AP | 1996-07-08 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1996-04-08 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1996-06-14 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1998-03-17 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1998-05-28 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1998-07-24 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1999-04-13 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1999-09-17 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 2002-04-01 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 2002-08-13 | PRIORITY |
LABELING; Labeling | SUPPL | 40 | AP | 2013-07-25 | PRIORITY |
LABELING; Labeling | SUPPL | 41 | AP | 2014-02-25 | PRIORITY |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 13 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 15 | Null | 0 |
SUPPL | 16 | Null | 0 |
SUPPL | 17 | Null | 0 |
SUPPL | 18 | Null | 0 |
SUPPL | 19 | Null | 0 |
SUPPL | 20 | Null | 0 |
SUPPL | 21 | Null | 0 |
SUPPL | 22 | Null | 0 |
SUPPL | 23 | Null | 0 |
SUPPL | 24 | Null | 0 |
SUPPL | 25 | Null | 0 |
SUPPL | 26 | Null | 0 |
SUPPL | 28 | Null | 0 |
SUPPL | 29 | Null | 0 |
SUPPL | 30 | Null | 0 |
SUPPL | 31 | Null | 0 |
SUPPL | 32 | Null | 0 |
SUPPL | 33 | Null | 0 |
SUPPL | 35 | Null | 0 |
SUPPL | 36 | Null | 0 |
SUPPL | 37 | Null | 0 |
SUPPL | 38 | Null | 0 |
SUPPL | 39 | Null | 0 |
SUPPL | 40 | Null | 0 |
SUPPL | 41 | Null | 0 |
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 18533
[companyName] => JANSSEN PHARMS
[docInserts] => ["Medication Guide","http:\/\/www.fda.gov\/downloads\/Drugs\/DrugSafety\/UCM362592.pdf"]
[products] => [{"drugName":"NIZORAL","activeIngredients":"KETOCONAZOLE","strength":"200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"02\/25\/2014","submission":"SUPPL-41","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/018533s041lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2013","submission":"SUPPL-40","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/018533s040lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"NIZORAL","submission":"KETOCONAZOLE","actionType":"200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2014-02-25
)
)