ANDA 62050, held by Pfizer. Ampicillin/Ampicillin Trihydrate.
As of Nov 15, 2026, ANDA 62050 (Pfizerpen-A), held by Pfizer, was first approved by FDA on Jul 5, 1977, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 5, 1977 | Original application | Approved | None posted |
| Pfizerpen-AEQ 250MG BASE · capsule;oral | Ampicillin/Ampicillin Trihydrate | Discontinued |
| Pfizerpen-AEQ 500MG BASE · capsule;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