Nallpen In Plastic Container

Treats infections caused by penicillinase-producing staphylococci. NDA 50655, held by Baxter Hlthcare. Nafcillin Sodium.

As of Nov 13, 2026, NDA 50655 (Nallpen In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Oct 31, 1989, with 16 approved supplements and 0 published complete response letters.

First approved: Oct 31, 1989
Review: Standard
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Culture and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see CLINICAL PHARMACOLOGY - Susceptibility Test Methods ). Nafcillin should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to methicillin-resistant Staphylococcus species, therapy with Nafcillin Injection, USP should be discontinued and alternative therapy provided.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Oct 31, 1989	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Nallpen In Plastic ContainerEQ 20MG BASE/ML · injectable;injection	Nafcillin Sodium	DiscontinuedReference drug
Nallpen In Plastic ContainerEQ 2GM BASE/100ML · injectable;injection	Nafcillin Sodium	RxReference drug

All 17 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 5, 2018	Supplement 26Labeling · Standard review	Approved	Label Letter
Jul 14, 2017	Supplement 25Labeling · Standard review	Approved	Label Letter
Apr 3, 2015	Supplement 23Labeling · Standard review	Approved	Label Letter
Nov 9, 2011	Supplement 18Labeling · Standard review	Approved	Letter Label
Apr 14, 2008	Supplement 17Labeling · Standard review	Approved	Label Letter
Aug 9, 2006	Supplement 16Labeling · Standard review	Approved	Letter
Aug 7, 2003	Supplement 13Labeling · Standard review	Approved	Letter
Aug 23, 2002	Supplement 12Labeling · Standard review	Approved	Letter
Aug 7, 1998	Supplement 11Manufacturing · Standard review	Approved	None posted
May 5, 1995	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 3, 1995	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 12, 1992	Supplement 7Labeling	Approved	None posted
Jul 17, 1992	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 25, 1992	Supplement 6Manufacturing · Standard review	Approved	None posted
Jan 28, 1992	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 22, 1991	Supplement 1Labeling	Approved	None posted
Oct 31, 1989	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50655
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

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