Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 019795
Company: TEVA BRANDED PHARM

Products on NDA 019795

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019795

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.

Therapeutic Equivalents for NDA 019795

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	TEVA BRANDED PHARM
PODOFILOX	PODOFILOX	0.5%	SOLUTION;TOPICAL	Prescription	No	AT	075600	PADAGIS US