Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208092
Company: P AND L
Company: P AND L
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MINOXIDIL (FOR MEN) | MINOXIDIL | 5% | AEROSOL, FOAM;TOPICAL | Over-the-counter | None | No | No |
| MINOXIDIL (FOR WOMEN) | MINOXIDIL | 5% | AEROSOL, FOAM;TOPICAL | Over-the-counter | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/27/2017 | ORIG-2 | Approval | STANDARD |
Label is not available on this site. |
|||
| 02/17/2017 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
FOR WOMEN
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208092Orig1s000ltr.pdf |
MINOXIDIL (FOR MEN)
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 |
MINOXIDIL (FOR WOMEN)
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 |