ANDA 221049, held by Humanwell Puracap. Lubiprostone.
As of Nov 14, 2026, ANDA 221049 (Lubiprostone), held by Humanwell Puracap, was first approved by FDA on Oct 14, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 14, 2026 | 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
