Documents
Application Sponsors
| NDA 021812 | JOHNSON AND JOHNSON | |
Marketing Status
| Over-the-counter | 001 |
| Over-the-counter | 002 |
Application Products
| 001 | AEROSOL, FOAM;TOPICAL | 5% | 1 | MEN'S ROGAINE | MINOXIDIL |
| 002 | AEROSOL, FOAM;TOPICAL | 5% | 1 | WOMEN'S ROGAINE | MINOXIDIL |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2006-01-20 | STANDARD Label for Men's Rogaine |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2012-11-30 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 9 | AP | 2014-02-28 | STANDARD Label for Women's Rogaine |
| LABELING; Labeling | SUPPL | 10 | AP | 2013-12-13 | STANDARD Label for Men?s Rogaine |
| LABELING; Labeling | SUPPL | 11 | AP | 2015-02-10 | STANDARD Label for Women?s Rogaine |
| LABELING; Labeling | SUPPL | 14 | AP | 2019-06-11 | STANDARD Label for Women?s Rogaine |
| LABELING; Labeling | SUPPL | 15 | AP | 2020-01-31 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2020-12-29 | STANDARD |
Submissions Property Types
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 15 |
| SUPPL | 10 | Null | 6 |
| SUPPL | 11 | Null | 6 |
| SUPPL | 14 | Null | 7 |
| SUPPL | 15 | Null | 15 |
| SUPPL | 16 | Null | 6 |
CDER Filings
JOHNSON AND JOHNSON
cder:Array
(
[0] => Array
(
[ApplNo] => 21812
[companyName] => JOHNSON AND JOHNSON
[docInserts] => ["",""]
[products] => [{"drugName":"MEN'S ROGAINE","activeIngredients":"MINOXIDIL","strength":"5%","dosageForm":"AEROSOL, FOAM;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"WOMEN'S ROGAINE","activeIngredients":"MINOXIDIL","strength":"5%","dosageForm":"AEROSOL, FOAM;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"01\/31\/2020","submission":"SUPPL-15","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021812s015lbl.pdf\"}]","notes":""},{"actionDate":"06\/11\/2019","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021812Orig1s014lbl.pdf\"}]","notes":"Label for Women\u2019s Rogaine"},{"actionDate":"06\/11\/2019","submission":"SUPPL-14","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021812Orig1s014lbl.pdf\"}]","notes":"Label for Women\u2019s Rogaine"},{"actionDate":"02\/10\/2015","submission":"SUPPL-11","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021812Orig1s011lbl.pdf\"}]","notes":"Label for Women\u2019s Rogaine"},{"actionDate":"02\/28\/2014","submission":"SUPPL-9","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021812Orig1s009lbl.pdf\"}]","notes":"Label for Women's Rogaine"},{"actionDate":"12\/13\/2013","submission":"SUPPL-10","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021812Orig1s010lbl.pdf\"}]","notes":"Label for Men\u2019s Rogaine"},{"actionDate":"01\/20\/2006","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021812s000LBL.pdf\"}]","notes":"Label for Men's Rogaine"}]
[originalApprovals] => [{"actionDate":"MEN'S ROGAINE","submission":"MINOXIDIL","actionType":"5%","submissionClassification":"AEROSOL, FOAM;TOPICAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"},{"actionDate":"WOMEN'S ROGAINE","submission":"MINOXIDIL","actionType":"5%","submissionClassification":"AEROSOL, FOAM;TOPICAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-01-31
)
)