Melphalan Hydrochloride
ANDA 203393, held by Fresenius Kabi USA. Melphalan Hydrochloride.
- First approved: Dec 22, 2017
- Supplements approved: 0
- Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 22, 2017 | Original application | Approved |
Products
1 strengths and forms| Product | Active ingredient | Marketing |
|---|---|---|
| Melphalan HydrochlorideEQ 50MG BASE/VIAL · injectable;injection | Melphalan Hydrochloride | Rx |
Identifiers
- Application
- ANDA 203393
- Drugs@FDA
- Overview at FDA
- Company
- Fresenius Kabi USA
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters