NDA 10375, held by 3m. Isoproterenol Sulfate, Isoproterenol Hydrochloride.
As of Nov 13, 2026, NDA 10375 (Medihaler-Iso, Isoproterenol Hydrochloride), held by 3m, was first approved by FDA on Mar 9, 1956, with 12 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 9, 1956 | Original applicationNew active ingredient · Standard review | Approved | None posted |
| Medihaler-Iso0.08MG/INH · aerosol, metered;inhalation | Isoproterenol Sulfate | Discontinued |
| Isoproterenol Hydrochloride0.12MG/INH · aerosol, metered;inhalation | Isoproterenol Hydrochloride | Discontinued |
| Mar 13, 2009 | Supplement 17Labeling | Approved | None posted |
| Dec 30, 1997 | Supplement 23Labeling · Standard review | Approved | None posted |
| Dec 20, 1993 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Dec 15, 1987 | Supplement 21Labeling | Approved | None posted |
| Feb 17, 1987 | Supplement 20Labeling | Approved | None posted |
| Mar 5, 1982 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Sep 18, 1978 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Apr 13, 1978 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Nov 9, 1976 | Supplement 14Labeling | Approved | None posted |
| Jul 29, 1975 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jul 28, 1975 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Jul 28, 1975 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Mar 9, 1956 | Original applicationNew active ingredient · 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
