ANDA 40090, held by Omnivium Pharms. Isoniazid.
As of Nov 15, 2026, ANDA 40090 (Isoniazid), held by Omnivium Pharms, was first approved by FDA on Jun 26, 1997, with 5 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Isoniazid 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 is recommended as preventive therapy for the following groups, regardless of age. (Note: the criterion for a positive reaction to a skin test (in millimeters of induration) for each group is given in parentheses): 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 26, 1997 | Original application | Approved | None posted |
| Feb 5, 2025 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jan 27, 2025 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jan 27, 2025 | Supplement 6Labeling · Standard review | Approved | None posted |
| Aug 13, 2002 | Supplement 2Manufacturing | Approved | None posted |
| Jul 31, 1998 | Supplement 1Manufacturing | Approved | None posted |
| Jun 26, 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
