Documents
Application Sponsors
| NDA 019501 | JOHNSON AND JOHNSON | |
Marketing Status
| Over-the-counter | 002 |
| Over-the-counter | 003 |
Application Products
| 002 | SOLUTION;TOPICAL | 2% | 1 | ROGAINE (FOR MEN) | MINOXIDIL |
| 003 | SOLUTION;TOPICAL | 2% | 1 | ROGAINE (FOR WOMEN) | MINOXIDIL |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1988-08-17 | PRIORITY |
| LABELING; Labeling | SUPPL | 2 | AP | 1989-09-19 | |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 1991-08-13 | |
| LABELING; Labeling | SUPPL | 4 | AP | 1990-03-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1990-02-12 | PRIORITY |
| LABELING; Labeling | SUPPL | 6 | AP | 1990-02-23 | |
| LABELING; Labeling | SUPPL | 7 | AP | 1990-10-05 | |
| LABELING; Labeling | SUPPL | 8 | AP | 1994-04-08 | |
| LABELING; Labeling | SUPPL | 9 | AP | 1992-09-24 | |
| LABELING; Labeling | SUPPL | 10 | AP | 1993-07-28 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 1993-07-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 12 | AP | 1996-02-09 | UNKNOWN |
| LABELING; Labeling | SUPPL | 13 | AP | 1994-12-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1996-03-11 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1998-04-16 | PRIORITY |
| LABELING; Labeling | SUPPL | 20 | AP | 2005-06-21 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2004-06-25 | PRIORITY |
| LABELING; Labeling | SUPPL | 25 | AP | 2005-06-21 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2015-04-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2016-05-24 | PRIORITY |
Submissions Property Types
| SUPPL | 5 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 29 | Null | 15 |
| SUPPL | 30 | Null | 0 |
CDER Filings
JOHNSON AND JOHNSON
cder:Array
(
[0] => Array
(
[ApplNo] => 19501
[companyName] => JOHNSON AND JOHNSON
[docInserts] => ["",""]
[products] => [{"drugName":"ROGAINE (FOR MEN)","activeIngredients":"MINOXIDIL","strength":"2%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"ROGAINE (FOR WOMEN)","activeIngredients":"MINOXIDIL","strength":"2%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"04\/27\/2015","submission":"SUPPL-29","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/019501Orig1s029lbl.pdf\"}]","notes":""},{"actionDate":"06\/21\/2005","submission":"SUPPL-25","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/019501s020,025lbl.pdf\"}]","notes":""},{"actionDate":"06\/21\/2005","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/019501s020,025lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ROGAINE (FOR MEN)","submission":"MINOXIDIL","actionType":"2%","submissionClassification":"SOLUTION;TOPICAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"},{"actionDate":"ROGAINE (FOR WOMEN)","submission":"MINOXIDIL","actionType":"2%","submissionClassification":"SOLUTION;TOPICAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2015-04-27
)
)