Nafcillin Sodium

ANDA 62844, held by Chartwell Rx. Nafcillin Sodium.

As of Nov 15, 2026, ANDA 62844 (Nafcillin Sodium), held by Chartwell Rx, was first approved by FDA on Oct 26, 1988, with 13 approved supplements and 0 published complete response letters.

First approved: Oct 26, 1988
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Oct 26, 1988	Original application	Approved	None posted

Products

5 strengths and forms


Nafcillin SodiumEQ 500MG BASE/VIAL · injectable;injection	Nafcillin Sodium	Discontinued
Nafcillin SodiumEQ 1GM BASE/VIAL · injectable;injection	Nafcillin Sodium	Discontinued
Nafcillin SodiumEQ 1.5GM BASE/VIAL · injectable;injection	Nafcillin Sodium	Discontinued
Nafcillin SodiumEQ 2GM BASE/VIAL · injectable;injection	Nafcillin Sodium	Discontinued
Nafcillin SodiumEQ 4GM BASE/VIAL · injectable;injection	Nafcillin Sodium	Discontinued

All 14 submissions, including labeling and manufacturing supplements


Dec 8, 2000	Supplement 18Manufacturing	Approved	None posted
Dec 29, 1997	Supplement 15Manufacturing	Approved	None posted
Mar 22, 1996	Supplement 13Labeling	Approved	None posted
Dec 15, 1995	Supplement 14Manufacturing	Approved	None posted
Jan 27, 1995	Supplement 12Manufacturing	Approved	None posted
Jan 13, 1994	Supplement 11Manufacturing	Approved	None posted
Dec 2, 1993	Supplement 10Manufacturing	Approved	None posted
Nov 9, 1993	Supplement 9Manufacturing	Approved	None posted
Feb 16, 1993	Supplement 6Manufacturing	Approved	None posted
Nov 7, 1990	Supplement 4Manufacturing	Approved	None posted
Dec 7, 1988	Supplement 3Manufacturing	Approved	None posted
Nov 10, 1988	Supplement 2Manufacturing	Approved	None posted
Nov 8, 1988	Supplement 1Manufacturing	Approved	None posted
Oct 26, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 62844
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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