NDA 18926, held by Pfizer. Ethinyl Estradiol; Ferrous Fumarate; Norethindrone.
As of Nov 13, 2026, NDA 18926 (Norquest Fe), held by Pfizer, was first approved by FDA on Jul 18, 1986, with 12 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 18, 1986 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Norquest Fe0.035MG;75MG;1MG · tablet;oral-28 | Ethinyl Estradiol; Ferrous Fumarate; Norethindrone | Discontinued |
| Apr 29, 2022 | Supplement 14Labeling · Standard review | Approved | |
| May 8, 2019 | Supplement 13Labeling · Standard review | Approved | |
| Mar 20, 2018 | Supplement 12Labeling · Standard review | Approved | |
| Aug 9, 2017 | Supplement 11Labeling · Standard review | Approved | |
| Jun 2, 1995 | Supplement 10Labeling · Standard review | Approved | None posted |
| Jul 31, 1992 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Nov 2, 1990 | Supplement 3Labeling | Approved | None posted |
| Sep 19, 1990 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Oct 24, 1989 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| May 17, 1989 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1989 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jan 14, 1987 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jul 18, 1986 | Original applicationNew formulation or manufacturer · 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
