Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019501
Company: JOHNSON AND JOHNSON
Company: JOHNSON AND JOHNSON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ROGAINE (FOR MEN) | MINOXIDIL | 2% | SOLUTION;TOPICAL | Over-the-counter | None | Yes | Yes |
| ROGAINE (FOR WOMEN) | MINOXIDIL | 2% | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 08/17/1988 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/24/2016 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/27/2015 | SUPPL-29 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019501Orig1s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019501Orig1s029ltr.pdf | |
| 06/21/2005 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019501s020,025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019501s020,025ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019501s025.pdf | |
| 06/25/2004 | SUPPL-24 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19501scs024ltr.pdf |
| 06/21/2005 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019501s020,025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019501s020,025ltr.pdf | |
| 04/16/1998 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/11/1996 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/01/1994 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 02/09/1996 | SUPPL-12 | Efficacy-Rx To OTC Switch |
Label is not available on this site. |
||
| 07/28/1993 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 07/28/1993 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 09/24/1992 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 04/08/1994 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 10/05/1990 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 02/23/1990 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 02/12/1990 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/23/1990 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 08/13/1991 | SUPPL-3 | Efficacy-New Indication |
Label is not available on this site. |
||
| 09/19/1989 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 08/24/1988 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/27/2015 | SUPPL-29 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019501Orig1s029lbl.pdf | |
| 06/21/2005 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019501s020,025lbl.pdf | |
| 06/21/2005 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019501s020,025lbl.pdf |
ROGAINE (FOR MEN)
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SOLUTION;TOPICAL; 2%
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| MINOXIDIL (FOR MEN) | MINOXIDIL | 2% | SOLUTION;TOPICAL | Over-the-counter | No | 074767 | AUROBINDO PHARMA LTD |
| MINOXIDIL (FOR MEN) | MINOXIDIL | 2% | SOLUTION;TOPICAL | Over-the-counter | No | 075357 | L PERRIGO CO |
| MINOXIDIL (FOR MEN) | MINOXIDIL | 2% | SOLUTION;TOPICAL | Over-the-counter | No | 074588 | P AND L |
| MINOXIDIL (FOR WOMEN) | MINOXIDIL | 2% | SOLUTION;TOPICAL | Over-the-counter | No | 075357 | L PERRIGO CO |
| ROGAINE (FOR MEN) | MINOXIDIL | 2% | SOLUTION;TOPICAL | Over-the-counter | Yes | 019501 | JOHNSON AND JOHNSON |
| ROGAINE (FOR WOMEN) | MINOXIDIL | 2% | SOLUTION;TOPICAL | Over-the-counter | Yes | 019501 | JOHNSON AND JOHNSON |
| THEROXIDIL | MINOXIDIL | 2% | SOLUTION;TOPICAL | Over-the-counter | No | 078176 | PURE SOURCE |
ROGAINE (FOR WOMEN)
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SOLUTION;TOPICAL; 2%
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| MINOXIDIL (FOR MEN) | MINOXIDIL | 2% | SOLUTION;TOPICAL | Over-the-counter | No | 074767 | AUROBINDO PHARMA LTD |
| MINOXIDIL (FOR MEN) | MINOXIDIL | 2% | SOLUTION;TOPICAL | Over-the-counter | No | 075357 | L PERRIGO CO |
| MINOXIDIL (FOR MEN) | MINOXIDIL | 2% | SOLUTION;TOPICAL | Over-the-counter | No | 074588 | P AND L |
| MINOXIDIL (FOR WOMEN) | MINOXIDIL | 2% | SOLUTION;TOPICAL | Over-the-counter | No | 075357 | L PERRIGO CO |
| ROGAINE (FOR MEN) | MINOXIDIL | 2% | SOLUTION;TOPICAL | Over-the-counter | Yes | 019501 | JOHNSON AND JOHNSON |
| ROGAINE (FOR WOMEN) | MINOXIDIL | 2% | SOLUTION;TOPICAL | Over-the-counter | Yes | 019501 | JOHNSON AND JOHNSON |
| THEROXIDIL | MINOXIDIL | 2% | SOLUTION;TOPICAL | Over-the-counter | No | 078176 | PURE SOURCE |