Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019385
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

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