Penbritin-S

NDA 50072, held by Wyeth Ayerst. Ampicillin Sodium.

As of Nov 13, 2026, NDA 50072 (Penbritin-S), held by Wyeth Ayerst, was first approved by FDA on Dec 29, 1966, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 29, 1966
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Dec 29, 1966	Original application	Approved	None posted

Products

6 strengths and forms


Penbritin-SEQ 125MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Ampicillin Sodium	DiscontinuedReference drug
Penbritin-SEQ 250MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Ampicillin Sodium	DiscontinuedReference drug
Penbritin-SEQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Ampicillin Sodium	DiscontinuedReference drug
Penbritin-SEQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Ampicillin Sodium	DiscontinuedReference drug
Penbritin-SEQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Ampicillin Sodium	DiscontinuedReference drug
Penbritin-SEQ 4GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Ampicillin Sodium	DiscontinuedReference drug

All 2 submissions, including labeling and manufacturing supplements


Nov 29, 1977	Supplement 3Labeling	Approved	None posted
Dec 29, 1966	Original application	Approved	None posted

Identifiers

Application: NDA 50072
Drugs@FDA: Overview at FDA
Company: Wyeth-Ayerst

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