Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075839
Company: APOTEX INC
Company: APOTEX INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MINOXIDIL EXTRA STRENGTH (FOR MEN) | MINOXIDIL | 5% | SOLUTION;TOPICAL | Discontinued | 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 |
|---|---|---|---|---|---|---|---|
| 10/01/2001 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-839_Minoxidil.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-839_Minoxidil.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/15/2007 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 04/12/2005 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 08/29/2003 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 12/09/2002 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/15/2002 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 02/15/2002 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |