Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020834
Company: JOHNSON AND JOHNSON
Company: JOHNSON AND JOHNSON
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ROGAINE EXTRA STRENGTH (FOR MEN) | MINOXIDIL | 5% | 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 |
---|---|---|---|---|---|---|---|
11/14/1997 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020834_rogaine_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/27/2015 | SUPPL-14 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020834Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020834Orig1s014ltr.pdf | |
09/12/2006 | SUPPL-11 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020834s011ltr.pdf |
05/31/2005 | SUPPL-9 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020834s009ltr.pdf |
06/25/2004 | SUPPL-7 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20834scs007ltr.pdf |
02/14/2003 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020834s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20834slr003ltr.pdf | |
04/16/1998 | SUPPL-1 | Manufacturing (CMC) |
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-14 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020834Orig1s014lbl.pdf | |
02/14/2003 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020834s003lbl.pdf |
ROGAINE EXTRA STRENGTH (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; 5%
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
MINOXIDIL EXTRA STRENGTH (FOR MEN) | MINOXIDIL | 5% | SOLUTION;TOPICAL | Over-the-counter | No | 075438 | AUROBINDO PHARMA LTD |
MINOXIDIL EXTRA STRENGTH (FOR MEN) | MINOXIDIL | 5% | SOLUTION;TOPICAL | Over-the-counter | No | 075518 | P AND L |
MINOXIDIL EXTRA STRENGTH (FOR MEN) | MINOXIDIL | 5% | SOLUTION;TOPICAL | Over-the-counter | No | 075598 | PERRIGO |
ROGAINE EXTRA STRENGTH (FOR MEN) | MINOXIDIL | 5% | SOLUTION;TOPICAL | Over-the-counter | Yes | 020834 | JOHNSON AND JOHNSON |
THEROXIDIL | MINOXIDIL | 5% | SOLUTION;TOPICAL | Over-the-counter | No | 076239 | PURE SOURCE |