ANDA 60127, held by Apothecon. Ampicillin/Ampicillin Trihydrate.
As of Nov 15, 2026, ANDA 60127 (Principen '250', Principen '125'), held by Apothecon, was not approved, with 0 approved supplements and 0 published complete response letters.
| Principen '250'EQ 250MG BASE/5ML · for suspension;oral | Ampicillin/Ampicillin Trihydrate | Discontinued |
| Principen '125'EQ 125MG 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
