ANDA 40310, held by Sun Pharma Canada. Hydrocortisone.
As of Nov 13, 2026, ANDA 40310 (Hydrocortisone), held by Sun Pharma Canada, was first approved by FDA on Dec 29, 2000, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 29, 2000 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydrocortisone2.5% ยท ointment;topical | Hydrocortisone | Discontinued |
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
