Drugs@FDA: FDA-Approved Drugs
Company: TARO
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 |
---|---|---|---|---|---|---|---|
04/22/2019 | ORIG-2 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209074Orig1s000TAltr.pdf | |
12/31/2018 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209074Orig1s000TAltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/04/2019 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
12/04/2019 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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 |