Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019795
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CONDYLOX PODOFILOX 0.5% SOLUTION;TOPICAL Prescription AT Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/13/1990 ORIG-1 Approval Type 3 - New Dosage Form 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
09/10/2015 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

10/30/2015 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/23/2013 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/17/2014 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/28/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/01/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/07/1994 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

11/03/1993 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/03/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/08/1991 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

CONDYLOX

SOLUTION;TOPICAL; 0.5%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CONDYLOX PODOFILOX 0.5% SOLUTION;TOPICAL Prescription Yes AT 019795 ALLERGAN
PODOFILOX PODOFILOX 0.5% SOLUTION;TOPICAL Prescription No AT 075600 PADDOCK LLC

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