Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075357
Company: L PERRIGO CO
Company: L PERRIGO CO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MINOXIDIL (FOR MEN) | MINOXIDIL | 2% | SOLUTION;TOPICAL | Over-the-counter | None | No | No |
| MINOXIDIL (FOR WOMEN) | MINOXIDIL | 2% | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 07/30/1999 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75357ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/075357Orig1s000.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/30/2016 | SUPPL-24 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 10/08/2008 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 07/14/2005 | SUPPL-5 | Labeling |
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.
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 |
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.
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 |