ANDA 85261, held by Ani Pharms. Aminophylline.
As of Nov 15, 2026, ANDA 85261 (Aminophylline), held by Ani Pharms, was first approved by FDA on Dec 22, 1976, with 15 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 22, 1976 | Original application | Approved | None posted |
| Aminophylline200MG · tablet;oral | Aminophylline | Discontinued |
| Aminophylline100MG · tablet;oral | Aminophylline | Discontinued |
| Jan 6, 1995 | Supplement 57Manufacturing | Approved | None posted |
| Dec 10, 1990 | Supplement 56Labeling | Approved | None posted |
| Nov 30, 1989 | Supplement 55Labeling | Approved | None posted |
| Nov 30, 1989 | Supplement 54Labeling | Approved | None posted |
| Jun 19, 1987 | Supplement 53Manufacturing | Approved | None posted |
| Jun 19, 1987 | Supplement 52Manufacturing | Approved | None posted |
| Jun 19, 1987 | Supplement 51Manufacturing | Approved | None posted |
| Jun 19, 1987 | Supplement 50Manufacturing | Approved | None posted |
| Aug 23, 1984 | Supplement 46Manufacturing | Approved | None posted |
| Aug 23, 1984 | Supplement 45Manufacturing | Approved | None posted |
| Feb 3, 1984 | Supplement 44Manufacturing | Approved | None posted |
| Nov 2, 1982 | Supplement 41Manufacturing | Approved | None posted |
| May 24, 1982 | Supplement 40Manufacturing | Approved | None posted |
| Dec 21, 1981 | Supplement 38Manufacturing | Approved | None posted |
| Dec 21, 1981 | Supplement 37Manufacturing | Approved | None posted |
| Dec 22, 1976 | 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
