NDA 17573, held by Schering. Beclomethasone Dipropionate.
As of Nov 13, 2026, NDA 17573 (Vanceril), held by Schering, was first approved by FDA on May 12, 1976, with 34 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 12, 1976 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vanceril0.042MG/INH · aerosol, metered;inhalation | Beclomethasone Dipropionate | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 30, 2000 | Supplement 45Manufacturing · Priority review | Approved | None posted |
| Jul 26, 2000 | Supplement 44Manufacturing · Priority review | Approved | None posted |
| Mar 11, 1999 | Supplement 41Manufacturing · Priority review | Approved | None posted |
| Feb 8, 1999 | Supplement 40Labeling · Priority review | Approved | |
| Nov 27, 1995 | Supplement 39Manufacturing · Priority review | Approved | None posted |
| Aug 3, 1995 | Supplement 38Manufacturing · Priority review | Approved | None posted |
| Aug 23, 1989 | Supplement 36Labeling · Priority review | Approved | None posted |
| Aug 2, 1988 | Supplement 34Manufacturing · Priority review | Approved | None posted |
| Feb 1, 1988 | Supplement 30Manufacturing · Priority review | Approved | None posted |
| Sep 24, 1987 | Supplement 31Manufacturing · Priority review | Approved | None posted |
| Jul 8, 1986 | Supplement 29Manufacturing · Priority review | Approved | None posted |
| Mar 6, 1986 | Supplement 28Manufacturing · Priority review | Approved | None posted |
| Feb 24, 1986 | Supplement 27Labeling · Priority review | Approved | None posted |
| Feb 24, 1986 | Supplement 26Manufacturing · Priority review | Approved | None posted |
| Feb 21, 1985 | Supplement 23Manufacturing · Priority review | Approved | None posted |
| Jan 2, 1985 | Supplement 24Manufacturing · Priority review | Approved | None posted |
| Dec 17, 1984 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| Feb 4, 1982 | Supplement 19Manufacturing · Priority review | Approved | None posted |
| Feb 2, 1982 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| Dec 3, 1981 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| Jun 30, 1981 | Supplement 14Labeling · Priority review | Approved | None posted |
| Jun 20, 1981 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| Mar 23, 1981 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Jan 13, 1981 | Supplement 13Labeling · Priority review | Approved | None posted |
| Jan 13, 1981 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| Nov 24, 1980 | Supplement 11Labeling · Priority review | Approved | None posted |
| Jun 23, 1980 | Supplement 9Labeling · Priority review | Approved | None posted |
| Jun 26, 1979 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Jun 15, 1979 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Jun 14, 1979 | Supplement 5Labeling · Priority review | Approved | None posted |
| Jun 14, 1979 | Supplement 2Labeling · Priority review | Approved | None posted |
| Apr 13, 1979 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Apr 6, 1979 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Mar 27, 1979 | Supplement 8Labeling · Priority review | Approved | None posted |
| May 12, 1976 | Original applicationNew molecular entity · Priority 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
