NDA 18761, held by Boehringer Ingelheim. Metaproterenol Sulfate.
As of Nov 13, 2026, NDA 18761 (Alupent), held by Boehringer Ingelheim, was first approved by FDA on Jun 30, 1983, with 13 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 30, 1983 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Alupent0.6% · solution;inhalation | Metaproterenol Sulfate | Discontinued |
| Alupent0.4% · solution;inhalation | Metaproterenol Sulfate | Discontinued |
| Jan 23, 2002 | Supplement 16Labeling · Standard review | Approved | |
| Oct 27, 1998 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Dec 2, 1997 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Aug 22, 1990 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Mar 14, 1990 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Dec 22, 1987 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1986 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1986 | Supplement 5Labeling · Standard review | Approved | None posted |
| Oct 10, 1986 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jul 10, 1986 | Supplement 7Labeling · Standard review | Approved | None posted |
| Oct 17, 1985 | Supplement 3Labeling · Standard review | Approved | None posted |
| Mar 2, 1985 | Supplement 2Labeling · Standard review | Approved | None posted |
| Mar 2, 1985 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jun 30, 1983 | Original applicationNew dosage form · 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
