Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020529
Company: ALLERGAN

Products on NDA 020529

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CONDYLOX	PODOFILOX	0.5%	GEL;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020529

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/13/1997	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1997/020529s000lbl.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/13/1997	SUPPL-1			Label is not available on this site.

Labels for NDA 020529

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/13/1997	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1997/020529s000lbl.pdf

Therapeutic Equivalents for NDA 020529

CONDYLOX

GEL;TOPICAL; 0.5%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CONDYLOX	PODOFILOX	0.5%	GEL;TOPICAL	Prescription	Yes	AB	020529	ALLERGAN
PODOFILOX	PODOFILOX	0.5%	GEL;TOPICAL	Prescription	No	AB	211871	PADAGIS US