For metastatic breast cancer. ANDA 76068, held by Hikma. Dexrazoxane Hydrochloride.
As of Nov 15, 2026, ANDA 76068 (Dexrazoxane Hydrochloride), held by Hikma, was first approved by FDA on Sep 28, 2004, with 1 approved supplement and 0 published complete response letters.
Dexrazoxane for injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m 2 and who will continue to receive doxorubicin therapy to maintain tumor control. Do not use with the initiation of doxorubicin therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 28, 2004 | Original application | Approved |
| Dexrazoxane HydrochlorideEQ 250MG BASE/VIAL · injectable;injection | Dexrazoxane Hydrochloride | Rx |
| Dexrazoxane HydrochlorideEQ 500MG BASE/VIAL · injectable;injection | Dexrazoxane Hydrochloride | Rx |
| Oct 5, 2017 | Supplement 15Manufacturing | Approved | None posted |
| Sep 28, 2004 | Original application | Approved |
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
