Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075518
Company: P AND L
Company: P AND L
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MINOXIDIL EXTRA STRENGTH (FOR MEN) | MINOXIDIL | 5% | 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 |
|---|---|---|---|---|---|---|---|
| 11/17/2000 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75518ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75518ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/29/2013 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 05/17/2005 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 06/15/2005 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 04/12/2005 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 10/04/2002 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/31/2001 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/31/2001 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 10/31/2001 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
MINOXIDIL 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 |
| MINOXIDIL EXTRA STRENGTH (FOR MEN) | MINOXIDIL | 5% | SOLUTION;TOPICAL | Over-the-counter | No | 217998 | TARO |
| ROGAINE EXTRA STRENGTH (FOR MEN) | MINOXIDIL | 5% | SOLUTION;TOPICAL | Over-the-counter | Yes | 020834 | KENVUE BRANDS |
| THEROXIDIL | MINOXIDIL | 5% | SOLUTION;TOPICAL | Over-the-counter | No | 076239 | PURE SOURCE |