Oxacillin Sodium

ANDA 62737, held by Sandoz. Oxacillin Sodium.

As of Nov 15, 2026, ANDA 62737 (Oxacillin Sodium), held by Sandoz, was first approved by FDA on Dec 23, 1986, with 6 approved supplements and 0 published complete response letters.

First approved: Dec 23, 1986
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Dec 23, 1986	Original application	Approved	None posted

Products

2 strengths and forms


Oxacillin SodiumEQ 1GM BASE/VIAL · powder;intravenous	Oxacillin Sodium	Discontinued
Oxacillin SodiumEQ 2GM BASE/VIAL · powder;intravenous	Oxacillin Sodium	Discontinued

All 7 submissions, including labeling and manufacturing supplements


May 25, 2016	Supplement 13Labeling	Approved	None posted
May 25, 2016	Supplement 17Labeling · Standard review	Approved	None posted
Oct 4, 2004	Supplement 5Labeling	Approved	None posted
Mar 26, 1996	Supplement 4Manufacturing	Approved	None posted
Oct 30, 1992	Supplement 2Manufacturing	Approved	None posted
Jul 24, 1990	Supplement 1Manufacturing	Approved	None posted
Dec 23, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 62737
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