ANDA 87727, held by Actavis Mid Atlantic. Aminophylline.
As of Nov 15, 2026, ANDA 87727 (Aminophylline Dye Free), held by Actavis Mid Atlantic, was first approved by FDA on Apr 16, 1982, with 17 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 16, 1982 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Aminophylline Dye Free105MG/5ML ยท solution;oral | Aminophylline | Discontinued |
| Nov 13, 2000 | Supplement 19Manufacturing | Approved | None posted |
| Sep 5, 1997 | Supplement 17Labeling | Approved | None posted |
| Jul 26, 1996 | Supplement 16Labeling | Approved | None posted |
| Dec 3, 1993 | Supplement 15Manufacturing | Approved | None posted |
| Mar 5, 1991 | Supplement 13Manufacturing | Approved | None posted |
| Sep 28, 1990 | Supplement 14Manufacturing | Approved | None posted |
| May 16, 1990 | Supplement 11Manufacturing | Approved | None posted |
| Apr 4, 1990 | Supplement 12Labeling | Approved | None posted |
| Dec 19, 1989 | Supplement 10Labeling | Approved | None posted |
| Nov 6, 1989 | Supplement 4Labeling | Approved | None posted |
| Oct 2, 1989 | Supplement 9Labeling | Approved | None posted |
| May 31, 1989 | Supplement 8Manufacturing | Approved | None posted |
| May 9, 1988 | Supplement 7Labeling | Approved | None posted |
| Aug 14, 1987 | Supplement 6Manufacturing | Approved | None posted |
| Aug 14, 1987 | Supplement 5Manufacturing | Approved | None posted |
| Apr 17, 1986 | Supplement 3Manufacturing | Approved | None posted |
| May 17, 1983 | Supplement 2Manufacturing | Approved | None posted |
| Apr 16, 1982 | 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
