Tobramycin Sulfate

ANDA 63111, held by Hospira. Tobramycin Sulfate.

First approved: Apr 30, 1991
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Apr 30, 1991	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tobramycin SulfateEQ 40MG BASE/ML · injectable;injection	Tobramycin Sulfate	Rx

All 13 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 10, 2023	Supplement 22Labeling · Standard review	Approved	None posted
Sep 21, 2015	Supplement 18Labeling · Standard review	Approved	None posted
Dec 8, 2011	Supplement 14Labeling	Approved	Label
Apr 7, 2005	Supplement 10Labeling	Approved	None posted
Apr 7, 2005	Supplement 11Labeling	Approved	None posted
Apr 27, 2004	Supplement 9Labeling	Approved	None posted
Oct 25, 2002	Supplement 8Manufacturing	Approved	None posted
Feb 16, 1999	Supplement 7Manufacturing	Approved	None posted
Oct 3, 1996	Supplement 5Manufacturing	Approved	None posted
Dec 10, 1993	Supplement 3Labeling	Approved	None posted
Apr 2, 1993	Supplement 2Manufacturing	Approved	None posted
Oct 30, 1991	Supplement 1Labeling	Approved	None posted
Apr 30, 1991	Original application	Approved	None posted

Identifiers

Application: ANDA 63111
Drugs@FDA: Overview at FDA
Company: Hospira

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters