NDA 12003, held by Abbvie. Biperiden Hydrochloride.
As of Nov 13, 2026, NDA 12003 (Akineton), held by Abbvie, was first approved by FDA on Sep 8, 1959, with 14 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 8, 1959 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Akineton2MG · tablet;oral | Biperiden Hydrochloride | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 9, 2002 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Feb 4, 2002 | Supplement 24Labeling · Standard review | Approved | |
| Jul 23, 2001 | Supplement 21Labeling | Approved | |
| Jul 23, 2001 | Supplement 20Labeling | Approved | |
| Jul 23, 2001 | Supplement 19Labeling | Approved | |
| Jul 23, 2001 | Supplement 18Labeling | Approved | |
| Oct 25, 2000 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Dec 17, 1987 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Jan 30, 1980 | Supplement 16Labeling | Approved | None posted |
| Jun 29, 1976 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Jan 14, 1976 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Sep 24, 1975 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| May 12, 1975 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Apr 2, 1975 | Supplement 10Labeling | Approved | None posted |
| Sep 8, 1959 | Original applicationNew molecular entity · Standard review | 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
