Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008173
Company: VALEANT PHARM INTL

Products on NDA 008173

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BENOQUIN	MONOBENZONE	20%	CREAM;TOPICAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 008173

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.

Labels for NDA 008173

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