NDA 211929, held by Sun Pharm Inds Inc. Budesonide.
As of Nov 14, 2026, NDA 211929 (Ortikos), held by Sun Pharm Inds Inc, was first approved by FDA on Jun 13, 2019, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 13, 2019 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Ortikos6MG · capsule, delayed release;oral | Budesonide | DiscontinuedReference drug |
| Ortikos9MG · capsule, delayed release;oral | Budesonide | DiscontinuedReference drug |
| Jun 5, 2024 | Supplement 11Labeling · Standard review | Approved | |
| Jun 29, 2022 | Supplement 8Labeling · Standard review | Approved | None posted |
| Jun 13, 2019 | Original applicationNew formulation or manufacturer · Standard review | Approved |
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
