NDA 9102, held by Glaxosmithkline. Piperazine Citrate.
As of Nov 13, 2026, NDA 9102 (Antepar), held by Glaxosmithkline, was first approved by FDA on Jan 25, 1957, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 25, 1957 | Original applicationNew active ingredient · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| AnteparEQ 500MG BASE/5ML · syrup;oral | Piperazine Citrate | Discontinued |
| AnteparEQ 500MG BASE · tablet;oral | Piperazine Citrate | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 26, 1996 | Supplement 3Labeling | Approved | None posted |
| Jan 25, 1957 | Original applicationNew active ingredient · Priority 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
