Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074924
Company: APOTEX INC
Company: APOTEX INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MINOXIDIL (FOR MEN) | MINOXIDIL | 2% | SOLUTION;TOPICAL | Discontinued | None | No | No |
| MINOXIDIL (FOR WOMEN) | MINOXIDIL | 2% | 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 |
|---|---|---|---|---|---|---|---|
| 04/29/1998 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74924ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/15/2007 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 06/07/2006 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 05/05/2005 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 03/18/2004 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 08/22/2002 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 08/22/2002 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/15/2001 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/19/2001 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 06/17/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |