ANDA 219519, held by Zydus Lifesciences. Rifabutin.
As of Nov 15, 2026, ANDA 219519 (Rifabutin), held by Zydus Lifesciences, was first approved by FDA on Aug 21, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 21, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rifabutin150MG ยท capsule;oral | Rifabutin | 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
