NDA 19795, held by Teva Branded Pharm. Podofilox.
As of Nov 13, 2026, NDA 19795 (Condylox), held by Teva Branded Pharm, was first approved by FDA on Dec 13, 1990, with 10 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 13, 1990 | Original applicationNew dosage form · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Condylox0.5% · solution;topical | Podofilox | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 30, 2015 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Sep 10, 2015 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Jan 17, 2014 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| May 23, 2013 | Supplement 13Manufacturing · Priority review | Approved | None posted |
| Jun 28, 1995 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| May 1, 1995 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Jan 7, 1994 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Nov 3, 1993 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Aug 3, 1993 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Nov 8, 1991 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Dec 13, 1990 | Original applicationNew dosage form · Priority review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
