Treats pulmonary tuberculosis. ANDA 78939, held by Lupin. Ethambutol Hydrochloride.
As of Nov 15, 2026, ANDA 78939 (Ethambutol Hydrochloride), held by Lupin, was first approved by FDA on Jun 17, 2009, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Ethambutol hydrochloride is indicated for the treatment of pulmonary tuberculosis. It should not be used as the sole antituberculous drug, but should be used in conjunction with at least one other antituberculous drug. Selection of the companion drug should be based on clinical experience, considerations of comparative safety and appropriate in-vitro susceptibility studies. In patients who have not received previous antituberculous therapy, i.e., initial treatment, the most frequently used regimens have been the following: Ethambutol plus isoniazid Ethambutol plus isoniazid plus streptomycin.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 17, 2009 | Original application | Approved | None posted |
| Ethambutol Hydrochloride100MG · tablet;oral | Ethambutol Hydrochloride | Rx |
| Ethambutol Hydrochloride400MG · tablet;oral | Ethambutol Hydrochloride | Rx |
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
