Tobramycin

Manages cystic fibrosis. ANDA 201422, held by Hikma. Tobramycin.

As of Nov 15, 2026, ANDA 201422 (Tobramycin), held by Hikma, was first approved by FDA on May 28, 2014, with 4 approved supplements and 0 published complete response letters.

First approved: May 28, 2014
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Tobramycin inhalation solution is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV 1 ) <25% or >75% predicted, or patients colonized with Burkholderia cepacia.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
May 28, 2014	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tobramycin300MG/5ML · solution;inhalation	Tobramycin	Rx

All 5 submissions, including labeling and manufacturing supplements


Sep 30, 2024	Supplement 9Labeling · Standard review	Approved	None posted
Jan 21, 2020	Supplement 1Labeling · Standard review	Approved	None posted
Jan 21, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Jan 21, 2020	Supplement 4Labeling · Standard review	Approved	None posted
May 28, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 201422
Drugs@FDA: Overview at FDA
Company: Hikma

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