Unipen

NDA 50462, held by Wyeth Ayerst. Nafcillin Sodium.

As of Nov 13, 2026, NDA 50462 (Unipen), held by Wyeth Ayerst, was first approved by FDA on Oct 16, 1973, with 19 approved supplements and 0 published complete response letters.

First approved: Oct 16, 1973
Review: Standard
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Oct 16, 1973	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
UnipenEQ 500MG BASE · tablet;oral	Nafcillin Sodium	Discontinued

All 20 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 10, 1991	Supplement 7Labeling · Standard review	Approved	None posted
Sep 28, 1987	Supplement 6Labeling · Standard review	Approved	None posted
Jan 20, 1987	Supplement 5Manufacturing · Standard review	Approved	None posted
Dec 5, 1986	Supplement 4Labeling · Standard review	Approved	None posted
Nov 21, 1986	Supplement 3Manufacturing · Standard review	Approved	None posted
Dec 28, 1982	Supplement 2Labeling · Standard review	Approved	None posted
Dec 14, 1982	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 3, 1982	Supplement 21Manufacturing · Standard review	Approved	None posted
Sep 30, 1980	Supplement 19Labeling · Standard review	Approved	None posted
Apr 24, 1978	Supplement 18Manufacturing · Standard review	Approved	None posted
Dec 22, 1977	Supplement 17Labeling · Standard review	Approved	None posted
Jun 2, 1977	Supplement 16Labeling · Standard review	Approved	None posted
Nov 22, 1976	Supplement 11Labeling · Standard review	Approved	None posted
Apr 21, 1976	Supplement 15Labeling · Standard review	Approved	None posted
Aug 19, 1975	Supplement 13Labeling · Standard review	Approved	None posted
Mar 23, 1975	Supplement 14Labeling · Standard review	Approved	None posted
Apr 11, 1974	Supplement 10Manufacturing · Standard review	Approved	None posted
Mar 8, 1974	Supplement 9Manufacturing · Standard review	Approved	None posted
Mar 8, 1974	Supplement 8Labeling · Standard review	Approved	None posted
Oct 16, 1973	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50462
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