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As of Nov 15, 2026, ANDA 40648 (Isoniazid), held by Sandoz, was first approved by FDA on Jul 5, 2005, with 2 approved supplements and 0 published complete response letters.
First approved: Jul 5, 2005
Supplements approved: 2
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
INDICATIONS AND USAGE Isoniazid Injection USP is recommended for all forms of tuberculosis in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant antituberculosis medications to prevent the emergence of drug resistance. Single-drug treatment of active tuberculosis with isoniazid, or any other medication, is inadequate therapy. Intramuscular administration is intended for use whenever administration by the oral route is not possible. Isoniazid is recommended as preventive therapy for the following groups, regardless of age.
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
