Oxacillin Sodium

ANDA 61490, held by Sandoz. Oxacillin Sodium.

As of Nov 15, 2026, ANDA 61490 (Oxacillin Sodium), held by Sandoz, was first approved by FDA on Apr 8, 1971, with 10 approved supplements and 0 published complete response letters.

First approved: Apr 8, 1971
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Apr 8, 1971	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 10GM BASE/VIAL · injectable;injection	Oxacillin Sodium	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Apr 11, 2016	Supplement 32Labeling	Approved	None posted
Apr 11, 2016	Supplement 37Manufacturing	Approved	None posted
Apr 11, 2016	Supplement 39Labeling · Standard review	Approved	None posted
Dec 2, 2014	Supplement 33Labeling	Approved	None posted
Mar 27, 2012	Supplement 35Labeling	Approved	None posted
Oct 4, 2004	Supplement 23Labeling	Approved	None posted
Oct 4, 2004	Supplement 24Labeling	Approved	None posted
Oct 4, 2004	Supplement 25Labeling	Approved	None posted
May 9, 1991	Supplement 20Labeling	Approved	None posted
Dec 22, 1989	Supplement 19Manufacturing	Approved	None posted
Apr 8, 1971	Original application	Approved	None posted

Identifiers

Application: ANDA 61490
Drugs@FDA: Overview at FDA
Company: Sandoz

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