ANDA 75866, held by Barr. Ethinyl Estradiol; Levonorgestrel.
As of Nov 15, 2026, ANDA 75866 (Portia-21, Portia-28), held by Barr, was first approved by FDA on May 23, 2002, with 10 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Portia (levonorgestrel and ethinyl estradiol tablets USP) is indicated for use by females of reproductive potential to prevent pregnancy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 23, 2002 | Original application | Approved | None posted |
| Portia-210.03MG;0.15MG · tablet;oral-21 | Ethinyl Estradiol; Levonorgestrel | Discontinued |
| Portia-280.03MG;0.15MG · tablet;oral-28 | Ethinyl Estradiol; Levonorgestrel | Rx |
| Feb 6, 2023 | Supplement 35Labeling · Standard review | Approved | None posted |
| Apr 29, 2022 | Supplement 32Labeling · Standard review | Approved | None posted |
| Mar 9, 2022 | Supplement 31Labeling · Standard review | Approved | None posted |
| Aug 9, 2017 | Supplement 26Labeling · Standard review | Approved | None posted |
| Feb 21, 2014 | Supplement 23Labeling · Standard review | Approved | None posted |
| Jan 3, 2003 | Supplement 5Manufacturing | Approved | None posted |
| Dec 6, 2002 | Supplement 1Manufacturing | Approved | None posted |
| Dec 6, 2002 | Supplement 2Manufacturing | Approved | None posted |
| Dec 6, 2002 | Supplement 3Manufacturing | Approved | None posted |
| Dec 6, 2002 | Supplement 4Manufacturing | Approved | None posted |
| May 23, 2002 | Original application | 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
