Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075598
Company: PERRIGO
Company: PERRIGO
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 |
---|---|---|---|---|---|---|---|
06/13/2001 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75598ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75598ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075598Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/21/2008 | SUPPL-18 | Labeling |
Label is not available on this site. |
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07/14/2005 | SUPPL-13 | Labeling |
Label is not available on this site. |
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08/30/2005 | SUPPL-9 | Labeling |
Label is not available on this site. |
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08/09/2004 | SUPPL-4 | Labeling |
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 |
ROGAINE EXTRA STRENGTH (FOR MEN) | MINOXIDIL | 5% | SOLUTION;TOPICAL | Over-the-counter | Yes | 020834 | JOHNSON AND JOHNSON |
THEROXIDIL | MINOXIDIL | 5% | SOLUTION;TOPICAL | Over-the-counter | No | 076239 | PURE SOURCE |