ANDA 90878, held by Apotex. Tamoxifen Citrate.
As of Nov 15, 2026, ANDA 90878 (Tamoxifen Citrate), held by Apotex, was first approved by FDA on Sep 23, 2011, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 23, 2011 | Original application | Approved | None posted |
| Tamoxifen CitrateEQ 10MG BASE · tablet;oral | Tamoxifen Citrate | Discontinued |
| Tamoxifen CitrateEQ 20MG BASE · tablet;oral | Tamoxifen Citrate | 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