NDA 50056, held by Apothecon. Ampicillin/Ampicillin Trihydrate.
As of Nov 13, 2026, NDA 50056 (Principen '250', Principen '500'), held by Apothecon, was not approved, with 0 approved supplements and 0 published complete response letters.
| Principen '250'EQ 250MG BASE · capsule;oral | Ampicillin/Ampicillin Trihydrate | DiscontinuedReference drug |
| Principen '500'EQ 500MG BASE · capsule;oral | Ampicillin/Ampicillin Trihydrate | DiscontinuedReference drug |
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
