Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021812
Company: JOHNSON AND JOHNSON
Company: JOHNSON AND JOHNSON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MEN'S ROGAINE | MINOXIDIL | 5% | AEROSOL, FOAM;TOPICAL | Over-the-counter | None | Yes | Yes |
| WOMEN'S ROGAINE | MINOXIDIL | 5% | AEROSOL, FOAM;TOPICAL | Over-the-counter | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/20/2006 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
Label for Men's Rogaine | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021812s000LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021812s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021812s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/29/2020 | SUPPL-16 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021812Orig1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021812Orig1s016ltr.pdf | |
| 01/31/2020 | SUPPL-15 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021812s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021812Orig1s015ltr.pdf | |
| 06/11/2019 | SUPPL-14 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Label for Women’s Rogaine | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021812Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021812Orig1s014ltr.pdf |
| 02/10/2015 | SUPPL-11 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
Label for Women’s Rogaine | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021812Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021812Orig1s011ltr.pdf |
| 12/13/2013 | SUPPL-10 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
Label for Men’s Rogaine | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021812Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021812Orig1s010ltr.pdf |
| 02/28/2014 | SUPPL-9 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
Label for Women's Rogaine | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021812Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021812Orig1s009ltr.pdf |
| 11/30/2012 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/22/2006 | SUPPL-1 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021812s001LTR.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/29/2020 | SUPPL-16 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021812Orig1s016lbl.pdf | |
| 01/31/2020 | SUPPL-15 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021812s015lbl.pdf | |
| 06/11/2019 | SUPPL-14 | Labeling-Container/Carton Labels | Label (PDF) | Label for Women’s Rogaine | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021812Orig1s014lbl.pdf |
| 06/11/2019 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | Label for Women’s Rogaine | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021812Orig1s014lbl.pdf |
| 02/10/2015 | SUPPL-11 | Labeling-Container/Carton Labels | Label (PDF) | Label for Women’s Rogaine | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021812Orig1s011lbl.pdf |
| 02/28/2014 | SUPPL-9 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | Label for Women's Rogaine | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021812Orig1s009lbl.pdf |
| 12/13/2013 | SUPPL-10 | Labeling-Container/Carton Labels | Label (PDF) | Label for Men’s Rogaine | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021812Orig1s010lbl.pdf |
| 01/20/2006 | ORIG-1 | Approval | Label (PDF) | Label for Men's Rogaine | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021812s000LBL.pdf |
MEN'S ROGAINE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
AEROSOL, FOAM;TOPICAL; 5%
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| MEN'S ROGAINE | MINOXIDIL | 5% | AEROSOL, FOAM;TOPICAL | Over-the-counter | Yes | 021812 | JOHNSON AND JOHNSON |
| MINOXIDIL | MINOXIDIL | 5% | AEROSOL, FOAM;TOPICAL | Over-the-counter | No | 091344 | PERRIGO PHARMA INTL |
| MINOXIDIL (FOR MEN) | MINOXIDIL | 5% | AEROSOL, FOAM;TOPICAL | Over-the-counter | No | 218616 | AUROBINDO PHARMA |
| MINOXIDIL (FOR MEN) | MINOXIDIL | 5% | AEROSOL, FOAM;TOPICAL | Over-the-counter | No | 208092 | P AND L |
| MINOXIDIL (FOR MEN) | MINOXIDIL | 5% | AEROSOL, FOAM;TOPICAL | Over-the-counter | No | 209074 | TARO |
| MINOXIDIL (FOR WOMEN) | MINOXIDIL | 5% | AEROSOL, FOAM;TOPICAL | Over-the-counter | No | 218616 | AUROBINDO PHARMA |
| MINOXIDIL (FOR WOMEN) | MINOXIDIL | 5% | AEROSOL, FOAM;TOPICAL | Over-the-counter | No | 208092 | P AND L |
| MINOXIDIL (FOR WOMEN) | MINOXIDIL | 5% | AEROSOL, FOAM;TOPICAL | Over-the-counter | No | 209074 | TARO |
| WOMEN'S ROGAINE | MINOXIDIL | 5% | AEROSOL, FOAM;TOPICAL | Over-the-counter | Yes | 021812 | JOHNSON AND JOHNSON |
WOMEN'S ROGAINE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
AEROSOL, FOAM;TOPICAL; 5%
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| MEN'S ROGAINE | MINOXIDIL | 5% | AEROSOL, FOAM;TOPICAL | Over-the-counter | Yes | 021812 | JOHNSON AND JOHNSON |
| MINOXIDIL | MINOXIDIL | 5% | AEROSOL, FOAM;TOPICAL | Over-the-counter | No | 091344 | PERRIGO PHARMA INTL |
| MINOXIDIL (FOR MEN) | MINOXIDIL | 5% | AEROSOL, FOAM;TOPICAL | Over-the-counter | No | 218616 | AUROBINDO PHARMA |
| MINOXIDIL (FOR MEN) | MINOXIDIL | 5% | AEROSOL, FOAM;TOPICAL | Over-the-counter | No | 208092 | P AND L |
| MINOXIDIL (FOR MEN) | MINOXIDIL | 5% | AEROSOL, FOAM;TOPICAL | Over-the-counter | No | 209074 | TARO |
| MINOXIDIL (FOR WOMEN) | MINOXIDIL | 5% | AEROSOL, FOAM;TOPICAL | Over-the-counter | No | 218616 | AUROBINDO PHARMA |
| MINOXIDIL (FOR WOMEN) | MINOXIDIL | 5% | AEROSOL, FOAM;TOPICAL | Over-the-counter | No | 208092 | P AND L |
| MINOXIDIL (FOR WOMEN) | MINOXIDIL | 5% | AEROSOL, FOAM;TOPICAL | Over-the-counter | No | 209074 | TARO |
| WOMEN'S ROGAINE | MINOXIDIL | 5% | AEROSOL, FOAM;TOPICAL | Over-the-counter | Yes | 021812 | JOHNSON AND JOHNSON |