Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074588
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 | 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 |
|---|---|---|---|---|---|---|---|
| 04/05/1996 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/13/2015 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 06/15/2005 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 05/17/2005 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 04/14/2005 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 04/14/2005 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 10/04/2002 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/27/2001 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 08/27/2001 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/29/1997 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/29/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/29/1997 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 02/24/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/1997 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 04/07/1997 | SUPPL-2 | Manufacturing (CMC) |
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 |