ANDA 84540, held by Hikma. Aminophylline.
As of Nov 15, 2026, ANDA 84540 (Aminophylline), held by Hikma, was first approved by FDA on Nov 26, 1975, with 20 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 26, 1975 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Aminophylline100MG ยท tablet;oral | Aminophylline | Discontinued |
| Jul 18, 2002 | Supplement 40Manufacturing | Approved | None posted |
| Jan 25, 2001 | Supplement 39Manufacturing | Approved | None posted |
| Jan 25, 2001 | Supplement 38Manufacturing | Approved | None posted |
| Jan 13, 2000 | Supplement 37Manufacturing | Approved | None posted |
| Oct 1, 1998 | Supplement 36Manufacturing | Approved | None posted |
| Sep 24, 1996 | Supplement 35Labeling | Approved | None posted |
| May 26, 1995 | Supplement 34Manufacturing | Approved | None posted |
| Jun 16, 1994 | Supplement 33Manufacturing | Approved | None posted |
| Jun 19, 1991 | Supplement 32Manufacturing | Approved | None posted |
| Apr 18, 1991 | Supplement 31Manufacturing | Approved | None posted |
| Sep 25, 1990 | Supplement 27Labeling | Approved | None posted |
| Jan 27, 1989 | Supplement 22Manufacturing | Approved | None posted |
| Apr 29, 1988 | Supplement 21Manufacturing | Approved | None posted |
| Apr 29, 1988 | Supplement 20Manufacturing | Approved | None posted |
| Apr 29, 1988 | Supplement 19Manufacturing | Approved | None posted |
| Feb 11, 1988 | Supplement 18Manufacturing | Approved | None posted |
| Mar 11, 1985 | Supplement 15Manufacturing | Approved | None posted |
| Mar 29, 1984 | Supplement 14Manufacturing | Approved | None posted |
| Jan 4, 1984 | Supplement 13Manufacturing | Approved | None posted |
| May 29, 1982 | Supplement 11Manufacturing | Approved | None posted |
| Nov 26, 1975 | 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
