ANDA 91540, held by Natco Pharma USA. Paclitaxel.
As of Nov 15, 2026, ANDA 91540 (Paclitaxel), held by Natco Pharma USA, was first approved by FDA on Sep 29, 2011, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 29, 2011 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Paclitaxel6MG/ML ยท injectable;injection | Paclitaxel | Discontinued |
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