NDA 16803, held by Sterling. Epinephrine.
As of Nov 13, 2026, NDA 16803 (Bronkaid Mist), held by Sterling, was first approved by FDA on Aug 11, 1969, with 11 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 11, 1969 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bronkaid Mist0.25MG/INH · aerosol, metered;inhalation | Epinephrine | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 15, 1995 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Dec 23, 1988 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Dec 21, 1988 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Nov 3, 1988 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Nov 25, 1986 | Supplement 10Labeling · Standard review | Approved | None posted |
| Jan 16, 1985 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| May 31, 1983 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Aug 26, 1980 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jun 21, 1978 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Mar 28, 1978 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Sep 2, 1975 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Aug 11, 1969 | 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
