ANDA 206994, held by Dr Reddys. Lubiprostone.
As of Nov 14, 2026, ANDA 206994 (Lubiprostone), held by Dr Reddys, was first approved by FDA on Feb 8, 2022, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 8, 2022 | Original application | Approved | None posted |
| Lubiprostone8MCG · capsule;oral | Lubiprostone | Rx |
| Lubiprostone24MCG · capsule;oral | Lubiprostone | Rx |
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
