Oxacillin Sodium

ANDA 62222, held by Ani Pharms. Oxacillin Sodium.

As of Nov 15, 2026, ANDA 62222 (Oxacillin Sodium), held by Ani Pharms, was first approved by FDA on Mar 10, 1980, with 3 approved supplements and 0 published complete response letters.

First approved: Mar 10, 1980
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Mar 10, 1980	Original application	Approved	None posted

Products

2 strengths and forms


Oxacillin SodiumEQ 250MG BASE · capsule;oral	Oxacillin Sodium	Discontinued
Oxacillin SodiumEQ 500MG BASE · capsule;oral	Oxacillin Sodium	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Jul 7, 2000	Supplement 3Manufacturing	Approved	None posted
Dec 10, 1997	Supplement 2Manufacturing	Approved	None posted
Aug 27, 1996	Supplement 1Manufacturing	Approved	None posted
Mar 10, 1980	Original application	Approved	None posted

Identifiers

Application: ANDA 62222
Drugs@FDA: Overview at FDA
Company: ANI Pharmaceuticals

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