ANDA 81118, held by Chartwell Rx. Isoniazid.
As of Nov 15, 2026, ANDA 81118 (Isoniazid), held by Chartwell Rx, was first approved by FDA on Jul 21, 1997, with 3 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Isoniazid oral solution is recommended for all forms of tuberculosis in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant anti-tuberculosis medications to prevent the emergence of drug resistance. Single-drug treatment of active tuberculosis with isoniazid or any other medication is inadequate therapy. Isoniazid oral solution is recommended as preventive therapy for the following groups, regardless of age.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 21, 1997 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Isoniazid50MG/5ML · syrup;oral | Isoniazid | Rx |
| Feb 5, 2025 | Supplement 4Labeling · Standard review | Approved | None posted |
| Nov 22, 2024 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jul 31, 1998 | Supplement 1Manufacturing | Approved | None posted |
| Jul 21, 1997 | Original application | Approved | None posted |
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
