Geocillin

NDA 50435, held by Pfizer. Carbenicillin Indanyl Sodium.

As of Nov 15, 2026, NDA 50435 (Geocillin), held by Pfizer, was first approved by FDA on Oct 26, 1972, with 5 approved supplements and 0 published complete response letters.

First approved: Oct 26, 1972
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Oct 26, 1972	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
GeocillinEQ 382MG BASE · tablet;oral	Carbenicillin Indanyl Sodium	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Feb 27, 2008	Supplement 9Labeling · Standard review	Approved	Letter Label
Dec 23, 2004	Supplement 8Labeling · Standard review	Approved	Letter
Nov 15, 1999	Supplement 7Manufacturing	Approved	None posted
Jul 17, 1992	Supplement 6Manufacturing	Approved	None posted
Aug 13, 1991	Supplement 5Manufacturing	Approved	None posted
Oct 26, 1972	Original application	Approved	None posted

Identifiers

Application: NDA 50435
Drugs@FDA: Overview at FDA
Company: Pfizer

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