NDA 20233, held by Astrazeneca. Budesonide.
As of Nov 13, 2026, NDA 20233 (Rhinocort), held by Astrazeneca, was first approved by FDA on Feb 14, 1994, with 11 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 14, 1994 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rhinocort0.032MG/INH · aerosol, metered;nasal | Budesonide | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 11, 2001 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Oct 2, 2001 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Jun 19, 2001 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Feb 21, 2001 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Jun 2, 2000 | Supplement 9Labeling · Standard review | Approved | None posted |
| Oct 21, 1999 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Sep 30, 1998 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jun 8, 1998 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Nov 15, 1996 | Supplement 4Labeling · Standard review | Approved | None posted |
| Nov 15, 1996 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Feb 7, 1996 | Supplement 3Labeling · Standard review | Approved | |
| Feb 14, 1994 | Original applicationNew molecular entity · Standard review | Approved | None posted |
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
