ANDA 87907, held by Armstrong Pharms. Epinephrine.
As of Nov 14, 2026, ANDA 87907 (Epinephrine), held by Armstrong Pharms, was first approved by FDA on May 23, 1984, with 17 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 23, 1984 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Epinephrine0.2MG/INH ยท aerosol, metered;inhalation | Epinephrine | Discontinued |
| Mar 25, 2010 | Supplement 38Labeling | Approved | None posted |
| Jun 12, 2009 | Supplement 34Labeling | Approved | None posted |
| May 9, 2008 | Supplement 24Labeling | Approved | None posted |
| Jul 9, 2002 | Supplement 20Labeling | Approved | None posted |
| Dec 4, 2001 | Supplement 19Manufacturing | Approved | None posted |
| May 4, 1995 | Supplement 18Labeling | Approved | None posted |
| Jul 28, 1993 | Supplement 17Labeling | Approved | None posted |
| Feb 26, 1993 | Supplement 15Manufacturing | Approved | None posted |
| Feb 26, 1993 | Supplement 14Manufacturing | Approved | None posted |
| Feb 26, 1993 | Supplement 13Manufacturing | Approved | None posted |
| Feb 26, 1993 | Supplement 12Manufacturing | Approved | None posted |
| Feb 15, 1991 | Supplement 10Labeling | Approved | None posted |
| Oct 25, 1990 | Supplement 11Labeling | Approved | None posted |
| Sep 28, 1990 | Supplement 16Manufacturing | Approved | None posted |
| May 16, 1990 | Supplement 7Labeling | Approved | None posted |
| May 16, 1990 | Supplement 6Manufacturing | Approved | None posted |
| Oct 2, 1989 | Supplement 2Labeling | Approved | None posted |
| May 23, 1984 | Original application | 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
