ANDA 70267, held by Teva. Indomethacin.
As of Nov 15, 2026, ANDA 70267 (Indo-Lemmon), held by Teva, was first approved by FDA on Nov 7, 1985, with 23 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 7, 1985 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Indo-Lemmon50MG ยท capsule;oral | Indomethacin | Discontinued |
| Aug 30, 2001 | Supplement 27Manufacturing | Approved | None posted |
| Oct 3, 1995 | Supplement 26Manufacturing | Approved | None posted |
| Oct 3, 1995 | Supplement 25Manufacturing | Approved | None posted |
| Oct 3, 1995 | Supplement 24Manufacturing | Approved | None posted |
| Mar 2, 1995 | Supplement 23Manufacturing | Approved | None posted |
| Jan 26, 1994 | Supplement 22Manufacturing | Approved | None posted |
| Jan 26, 1994 | Supplement 21Manufacturing | Approved | None posted |
| Jan 26, 1994 | Supplement 20Manufacturing | Approved | None posted |
| Jan 26, 1994 | Supplement 19Manufacturing | Approved | None posted |
| Jan 26, 1994 | Supplement 18Manufacturing | Approved | None posted |
| Jan 26, 1994 | Supplement 17Manufacturing | Approved | None posted |
| Apr 1, 1993 | Supplement 16Manufacturing | Approved | None posted |
| Apr 1, 1993 | Supplement 15Manufacturing | Approved | None posted |
| Apr 1, 1993 | Supplement 14Manufacturing | Approved | None posted |
| Sep 10, 1991 | Supplement 13Labeling | Approved | None posted |
| Mar 23, 1990 | Supplement 10Labeling | Approved | None posted |
| Mar 23, 1990 | Supplement 9Manufacturing | Approved | None posted |
| Jun 30, 1989 | Supplement 12Labeling | Approved | None posted |
| Feb 22, 1989 | Supplement 11Labeling | Approved | None posted |
| Apr 22, 1988 | Supplement 7Manufacturing | Approved | None posted |
| Jul 17, 1987 | Supplement 5Manufacturing | Approved | None posted |
| Jul 17, 1987 | Supplement 4Manufacturing | Approved | None posted |
| Jul 17, 1987 | Supplement 3Manufacturing | Approved | None posted |
| Nov 7, 1985 | 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
