Staphcillin

ANDA 61449, held by Apothecon. Methicillin Sodium.

As of Nov 15, 2026, ANDA 61449 (Staphcillin), held by Apothecon, was first approved by FDA on Apr 1, 1971, with 1 approved supplement and 0 published complete response letters.

First approved: Apr 1, 1971
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
Apr 1, 1971	Original application	Approved	None posted

Products

3 strengths and forms


StaphcillinEQ 900MG BASE/VIAL · injectable;injection	Methicillin Sodium	Discontinued
StaphcillinEQ 3.6GM BASE/VIAL · injectable;injection	Methicillin Sodium	Discontinued
StaphcillinEQ 5.4GM BASE/VIAL · injectable;injection	Methicillin Sodium	Discontinued

All 2 submissions, including labeling and manufacturing supplements


May 21, 1991	Supplement 11Labeling	Approved	None posted
Apr 1, 1971	Original application	Approved	None posted

Identifiers

Application: ANDA 61449
Drugs@FDA: Overview at FDA
Company: Apothecon

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