Oxacillin Sodium

ANDA 91246, held by Sagent Pharms. Oxacillin Sodium.

As of Nov 15, 2026, ANDA 91246 (Oxacillin Sodium), held by Sagent Pharms, was first approved by FDA on Mar 30, 2012, with 1 approved supplement and 0 published complete response letters.

First approved: Mar 30, 2012
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
Mar 30, 2012	Original application	Approved	Review

Products

2 strengths and forms


Oxacillin SodiumEQ 1GM BASE/VIAL · injectable;injection	Oxacillin Sodium	Discontinued
Oxacillin SodiumEQ 2GM BASE/VIAL · injectable;injection	Oxacillin Sodium	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Apr 4, 2016	Supplement 1Labeling · Standard review	Approved	None posted
Mar 30, 2012	Original application	Approved	Review

Identifiers

Application: ANDA 91246
Drugs@FDA: Overview at FDA
Company: Sagent 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