ANDA 91328, held by Lupin Ltd. Levonorgestrel.
As of Nov 13, 2026, ANDA 91328 (Levonorgestrel), held by Lupin Ltd, was first approved by FDA on Jan 23, 2013, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 23, 2013 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levonorgestrel0.75MG · tablet;oral | Levonorgestrel | Discontinued |
| Levonorgestrel0.75MG · tablet; oral | Levonorgestrel | OTC |
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
