Tobramycin

ANDA 210915, held by Teva Pharms USA. Tobramycin.

As of Nov 15, 2026, ANDA 210915 (Tobramycin), held by Teva Pharms USA, was first approved by FDA on Jun 26, 2019, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 26, 2019
Review: Standard
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
Jun 26, 2019	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tobramycin300MG/4ML · solution;inhalation	Tobramycin	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Nov 21, 2023	Supplement 1Labeling · Standard review	Approved	None posted
Jun 26, 2019	Original application	Approved	Letter

Identifiers

Application: ANDA 210915
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals USA

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