Treats pulmonary tuberculosis. ANDA 75095, held by Epic Pharma LLC. Ethambutol Hydrochloride.
As of Nov 15, 2026, ANDA 75095 (Ethambutol Hydrochloride), held by Epic Pharma LLC, was first approved by FDA on Nov 30, 1999, with 4 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Ethambutol Hydrochloride Tablets, USP are 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 30, 1999 | Original application | Approved |
| Ethambutol Hydrochloride100MG · tablet;oral | Ethambutol Hydrochloride | Rx |
| Ethambutol Hydrochloride400MG · tablet;oral | Ethambutol Hydrochloride | Rx |
| Jan 27, 2012 | Supplement 6Labeling | Approved | None posted |
| Aug 22, 2006 | Supplement 5Labeling | Approved | None posted |
| Feb 1, 2002 | Supplement 1Manufacturing | Approved | None posted |
| Feb 1, 2002 | Supplement 2Manufacturing | Approved | None posted |
| Nov 30, 1999 | Original application | Approved |
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
