NDA 18206, held by Cadence Health. Ethinyl Estradiol; Levonorgestrel; Ferrous Fumarate.
As of Nov 13, 2026, NDA 18206 (Lo/Ovral Fe), held by Cadence Health, was first approved by FDA on Jul 26, 1979, with 13 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 26, 1979 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lo/Ovral Fe0.03MG,0.3MG;75MG · tablet;oral | Ethinyl Estradiol; Levonorgestrel; Ferrous Fumarate | Rx |
| Apr 29, 2022 | Supplement 22Labeling · Standard review | Approved | |
| Oct 18, 2017 | Supplement 20Labeling · Standard review | Approved | |
| Aug 9, 2017 | Supplement 21Labeling · Standard review | Approved | |
| Mar 6, 2002 | Supplement 14Manufacturing | Approved | None posted |
| May 24, 2001 | Supplement 13Labeling · Standard review | Approved | None posted |
| May 3, 1995 | Supplement 11Labeling · Standard review | Approved | None posted |
| Nov 29, 1994 | Supplement 10Labeling · Standard review | Approved | None posted |
| Jun 8, 1988 | Supplement 9Manufacturing | Approved | None posted |
| May 14, 1985 | Supplement 7Manufacturing | Approved | None posted |
| Aug 23, 1984 | Supplement 6Labeling | Approved | None posted |
| Feb 10, 1984 | Supplement 5Manufacturing | Approved | None posted |
| Feb 17, 1983 | Supplement 4Labeling | Approved | None posted |
| Dec 7, 1982 | Supplement 1Manufacturing | Approved | None posted |
| Jul 26, 1979 | Original applicationNew dosage form · Standard 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
