ANDA 88887, held by Pliva. Amitriptyline Hydrochloride.
As of Nov 15, 2026, ANDA 88887 (Amitriptyline Hydrochloride), held by Pliva, was first approved by FDA on Sep 26, 1984, with 16 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 26, 1984 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Amitriptyline Hydrochloride100MG ยท tablet;oral | Amitriptyline Hydrochloride | Discontinued |
| Jun 25, 2001 | Supplement 19Labeling | Approved | None posted |
| Oct 5, 2000 | Supplement 17Labeling | Approved | None posted |
| Jul 7, 2000 | Supplement 16Manufacturing | Approved | None posted |
| Jul 14, 1995 | Supplement 14Manufacturing | Approved | None posted |
| Jul 14, 1995 | Supplement 13Labeling | Approved | None posted |
| May 24, 1995 | Supplement 15Labeling | Approved | None posted |
| May 11, 1994 | Supplement 12Manufacturing | Approved | None posted |
| Nov 4, 1993 | Supplement 11Labeling | Approved | None posted |
| May 26, 1992 | Supplement 10Labeling | Approved | None posted |
| Jul 29, 1991 | Supplement 6Manufacturing | Approved | None posted |
| Oct 26, 1990 | Supplement 8Labeling | Approved | None posted |
| Feb 14, 1990 | Supplement 7Bioequivalence | Approved | None posted |
| Mar 22, 1988 | Supplement 5Manufacturing | Approved | None posted |
| Jun 17, 1985 | Supplement 3Manufacturing | Approved | None posted |
| Jun 17, 1985 | Supplement 2Manufacturing | Approved | None posted |
| Jun 17, 1985 | Supplement 1Manufacturing | Approved | None posted |
| Sep 26, 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
