ANDA 61980, held by Purepac Pharm. Ampicillin/Ampicillin Trihydrate.
As of Nov 15, 2026, ANDA 61980 (Ampicillin Trihydrate), held by Purepac Pharm, was first approved by FDA on May 4, 1976, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 4, 1976 | Original application | Approved | None posted |
| Ampicillin TrihydrateEQ 125MG BASE/5ML · for suspension;oral | Ampicillin/Ampicillin Trihydrate | Discontinued |
| Ampicillin TrihydrateEQ 250MG BASE/5ML · for suspension;oral | Ampicillin/Ampicillin Trihydrate | Discontinued |
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
