Unipen

NDA 50199, held by Wyeth Ayerst. Nafcillin Sodium.

As of Nov 13, 2026, NDA 50199 (Unipen), held by Wyeth Ayerst, was first approved by FDA on Oct 11, 1965, with 26 approved supplements and 0 published complete response letters.

First approved: Oct 11, 1965
Supplements approved: 26
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below

Date	Submission	Status	Documents
Oct 11, 1965	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
UnipenEQ 250MG BASE/5ML · for solution;oral	Nafcillin Sodium	Discontinued

All 27 submissions, including labeling and manufacturing supplements


May 14, 1991	Supplement 6Manufacturing	Approved	None posted
Apr 10, 1991	Supplement 5Labeling	Approved	None posted
Sep 15, 1987	Supplement 4Labeling	Approved	None posted
Dec 5, 1986	Supplement 3Labeling	Approved	None posted
Aug 27, 1985	Supplement 2Labeling	Approved	None posted
Dec 28, 1982	Supplement 1Labeling	Approved	None posted
Jul 28, 1982	Supplement 26Manufacturing	Approved	None posted
Oct 22, 1980	Supplement 25Manufacturing	Approved	None posted
Oct 3, 1980	Supplement 24Labeling	Approved	None posted
Oct 2, 1980	Supplement 23Labeling	Approved	None posted
May 15, 1980	Supplement 22Manufacturing	Approved	None posted
Apr 24, 1978	Supplement 21Manufacturing	Approved	None posted
Apr 18, 1978	Supplement 20Manufacturing	Approved	None posted
Dec 22, 1977	Supplement 19Labeling	Approved	None posted
Oct 15, 1976	Supplement 18Manufacturing	Approved	None posted
Sep 7, 1976	Supplement 17Labeling	Approved	None posted
Jul 26, 1976	Supplement 15Manufacturing	Approved	None posted
Jul 26, 1976	Supplement 14Manufacturing	Approved	None posted
May 4, 1976	Supplement 16Manufacturing	Approved	None posted
Apr 11, 1974	Supplement 13Manufacturing	Approved	None posted
Jan 24, 1973	Supplement 12Manufacturing	Approved	None posted
May 6, 1970	Supplement 11Manufacturing	Approved	None posted
May 6, 1970	Supplement 10Manufacturing	Approved	None posted
Oct 16, 1967	Supplement 9Manufacturing	Approved	None posted
Aug 5, 1966	Supplement 8Manufacturing	Approved	None posted
Mar 10, 1966	Supplement 7Manufacturing	Approved	None posted
Oct 11, 1965	Original application	Approved	None posted

Identifiers

Application: NDA 50199
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