ANDA 88235, held by Cmp Pharma Inc. Isoniazid.
As of Nov 15, 2026, ANDA 88235 (Isoniazid), held by Cmp Pharma Inc, was first approved by FDA on Nov 10, 1983, with 7 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 |
|---|---|---|---|
| Nov 10, 1983 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Isoniazid50MG/5ML · syrup;oral | Isoniazid | RxReference drug |
| Feb 5, 2025 | Supplement 11Labeling · Standard review | Approved | None posted |
| Jan 29, 2025 | Supplement 8Labeling · Standard review | Approved | None posted |
| Aug 9, 2000 | Supplement 6Manufacturing | Approved | None posted |
| Sep 14, 1999 | Supplement 5Labeling | Approved | None posted |
| Dec 14, 1992 | Supplement 4Manufacturing | Approved | None posted |
| Mar 20, 1991 | Supplement 3Manufacturing | Approved | None posted |
| May 29, 1986 | Supplement 1Manufacturing | Approved | None posted |
| Nov 10, 1983 | 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
