Oxacillin Sodium

ANDA 62856, held by Chartwell Rx. Oxacillin Sodium.

As of Nov 15, 2026, ANDA 62856 (Oxacillin Sodium), held by Chartwell Rx, was first approved by FDA on Oct 26, 1988, with 18 approved supplements and 0 published complete response letters.

First approved: Oct 26, 1988
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

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

Products

5 strengths and forms


Oxacillin SodiumEQ 250MG BASE/VIAL · injectable;injection	Oxacillin Sodium	Discontinued
Oxacillin SodiumEQ 500MG BASE/VIAL · injectable;injection	Oxacillin Sodium	Discontinued
Oxacillin SodiumEQ 1GM BASE/VIAL · injectable;injection	Oxacillin Sodium	Discontinued
Oxacillin SodiumEQ 2GM BASE/VIAL · injectable;injection	Oxacillin Sodium	Discontinued
Oxacillin SodiumEQ 4GM BASE/VIAL · injectable;injection	Oxacillin Sodium	Discontinued

All 19 submissions, including labeling and manufacturing supplements


Dec 8, 2000	Supplement 22Manufacturing	Approved	None posted
May 14, 1999	Supplement 21Manufacturing	Approved	None posted
Sep 29, 1998	Supplement 20Manufacturing	Approved	None posted
Sep 18, 1998	Supplement 19Manufacturing	Approved	None posted
Sep 18, 1998	Supplement 18Labeling	Approved	None posted
Dec 22, 1997	Supplement 15Manufacturing	Approved	None posted
Feb 10, 1995	Supplement 14Manufacturing	Approved	None posted
Jan 27, 1995	Supplement 13Manufacturing	Approved	None posted
Jan 13, 1994	Supplement 12Manufacturing	Approved	None posted
Dec 1, 1993	Supplement 11Manufacturing	Approved	None posted
Dec 1, 1993	Supplement 10Manufacturing	Approved	None posted
Dec 1, 1993	Supplement 9Manufacturing	Approved	None posted
Nov 18, 1993	Supplement 8Manufacturing	Approved	None posted
Nov 18, 1993	Supplement 7Labeling	Approved	None posted
Mar 11, 1992	Supplement 5Manufacturing	Approved	None posted
Nov 9, 1990	Supplement 3Manufacturing	Approved	None posted
Dec 7, 1988	Supplement 2Manufacturing	Approved	None posted
Nov 10, 1988	Supplement 1Manufacturing	Approved	None posted
Oct 26, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 62856
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