ANDA 73594, held by Dr Reddys Labs SA. Ethinyl Estradiol; Levonorgestrel.
As of Nov 15, 2026, ANDA 73594 (Levora 0.15/30-28), held by Dr Reddys Labs SA, was first approved by FDA on Dec 13, 1993, with 10 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE LEVORA 0.15/30-28 is indicated for use by females of reproductive potential to prevent pregnancy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 13, 1993 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levora 0.15/30-280.03MG;0.15MG · tablet;oral-28 | Ethinyl Estradiol; Levonorgestrel | Rx |
| Apr 29, 2022 | Supplement 31Labeling · Standard review | Approved | None posted |
| Mar 7, 2022 | Supplement 28Labeling · Standard review | Approved | None posted |
| Mar 7, 2022 | Supplement 30Labeling · Standard review | Approved | None posted |
| Aug 9, 2017 | Supplement 26Labeling · Standard review | Approved | None posted |
| Jul 24, 2017 | Supplement 25Labeling · Standard review | Approved | None posted |
| Feb 7, 2014 | Supplement 24Labeling · Standard review | Approved | None posted |
| Aug 16, 2001 | Supplement 6Manufacturing | Approved | None posted |
| Oct 31, 1996 | Supplement 3Manufacturing | Approved | None posted |
| Jul 10, 1996 | Supplement 2Labeling | Approved | None posted |
| Jun 10, 1996 | Supplement 1Manufacturing | Approved | None posted |
| Dec 13, 1993 | 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
