Oxacillin Sodium

ANDA 62798, held by Acs Dobfar Spa. Oxacillin Sodium.

As of Nov 15, 2026, ANDA 62798 (Oxacillin Sodium), held by Acs Dobfar Spa, was first approved by FDA on Dec 11, 1995, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 11, 1995
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Dec 11, 1995	Original application	Approved	None posted

Products

5 strengths and forms


Oxacillin SodiumEQ 1GM BASE/VIAL · injectable;injection	Oxacillin Sodium	Discontinued
Oxacillin SodiumEQ 2GM BASE/VIAL · injectable;injection	Oxacillin Sodium	Discontinued
Oxacillin SodiumEQ 125MG BASE/VIAL · injectable;injection	Oxacillin Sodium	Discontinued
Oxacillin SodiumEQ 250MG BASE/VIAL · injectable;injection	Oxacillin Sodium	Discontinued
Oxacillin SodiumEQ 500MG BASE/VIAL · injectable;injection	Oxacillin Sodium	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Feb 7, 2020	Supplement 1Labeling · Standard review	Approved	None posted
Dec 11, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 62798
Drugs@FDA: Overview at FDA
Company: ACS Dobfar

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