Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008173
Company: VALEANT PHARM INTL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BENOQUIN MONOBENZONE 20% CREAM;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
11/10/1952 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
03/26/2003 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08173slr015_benoquin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08173slr015ltr.pdf
03/16/1998 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/07/1997 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

09/23/1997 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

04/03/1997 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

01/31/1997 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

01/17/1995 SUPPL-9 Labeling

Label is not available on this site.

04/27/1993 SUPPL-8 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/27/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/08/1984 SUPPL-6 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/26/2003 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08173slr015_benoquin_lbl.pdf

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