For adrenocortical insufficiency. NDA 213876, held by Eton. Hydrocortisone.
As of Nov 13, 2026, NDA 213876 (Alkindi Sprinkle), held by Eton, was first approved by FDA on Sep 29, 2020, with 3 approved supplements and 0 published complete response letters.
ALKINDI SPRINKLE is indicated as replacement therapy in pediatric patients with adrenocortical insufficiency.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 29, 2020 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Alkindi Sprinkle0.5MG · granule;oral | Hydrocortisone | RxReference drug |
| Alkindi Sprinkle1MG · granule;oral | Hydrocortisone | RxReference drug |
| Alkindi Sprinkle2MG · granule;oral | Hydrocortisone | RxReference drug |
| Alkindi Sprinkle5MG · granule;oral | Hydrocortisone | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 5, 2024 | Supplement 5Labeling · Standard review | Approved | |
| Dec 23, 2022 | Supplement 2Labeling · Standard review | Approved | |
| Feb 3, 2022 | Supplement 1Labeling · Standard review | Approved | |
| Sep 29, 2020 | Original applicationNew dosage form · 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
