Drugs@FDA: FDA-Approved Drugs
Company: VALEANT PHARM INTL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PERMAX | PERGOLIDE MESYLATE | EQ 0.05MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| PERMAX | PERGOLIDE MESYLATE | EQ 0.25MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| PERMAX | PERGOLIDE MESYLATE | EQ 1MG BASE | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 12/30/1988 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/02/2003 | SUPPL-35 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19385slr030,031,035_permax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19385slr030,031,035ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019385_S035_PERMAX.pdf | |
| 05/17/2002 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/02/2003 | SUPPL-31 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19385slr030,031,035_permax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19385slr030,031,035ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019385_S031_PERMAX.pdf | |
| 10/02/2003 | SUPPL-30 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19385slr030,031,035_permax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19385slr030,031,035ltr.pdf | |
| 12/07/2000 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/2002 | SUPPL-28 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19385slr028ltr.pdf |
| 10/01/1999 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/06/1999 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 04/13/1999 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/26/1998 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/13/1998 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1998 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/06/1999 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 10/06/1999 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 10/06/1999 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 10/06/1999 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 11/29/1994 | SUPPL-14 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/15/1994 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/15/1994 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/15/1994 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/11/1993 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/11/1993 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/06/1999 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 01/08/1993 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/15/1991 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/08/1993 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/06/1999 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 11/27/1989 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/02/1989 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 03/17/1989 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/02/2003 | SUPPL-35 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19385slr030,031,035_permax_lbl.pdf | |
| 10/02/2003 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19385slr030,031,035_permax_lbl.pdf | |
| 10/02/2003 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19385slr030,031,035_permax_lbl.pdf |