NDA 21040, held by Teva Womens. Estradiol; Norgestimate.
As of Nov 14, 2026, NDA 21040 (Prefest), held by Teva Womens, was first approved by FDA on Oct 22, 1999, with 13 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 22, 1999 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Prefest1MG,1MG;N/A,0.09MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Estradiol; Norgestimate | DiscontinuedReference drug |
| Feb 15, 2024 | Supplement 15Labeling · Standard review | Approved | |
| Nov 1, 2017 | Supplement 13Labeling · Standard review | Approved | |
| Jul 13, 2004 | Supplement 12Labeling · Standard review | Approved | |
| Dec 19, 2003 | Supplement 9Labeling · Standard review | Approved | |
| Dec 19, 2003 | Supplement 7Labeling · Standard review | Approved | |
| Dec 19, 2003 | Supplement 5Labeling · Standard review | Approved | |
| Dec 19, 2003 | Supplement 2Labeling · Standard review | Approved | |
| Dec 19, 2003 | Supplement 1Labeling · Standard review | Approved | |
| Jan 23, 2003 | Supplement 10Labeling · Standard review | Approved | |
| Nov 13, 2002 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Oct 30, 2001 | Supplement 8Labeling · Standard review | Approved | None posted |
| Jan 18, 2001 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Nov 6, 2000 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Oct 22, 1999 | Original applicationNew combination · Standard review | Approved |
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
