Orange Book product
DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML
Orange Book ANDA 208759 · HISUN PHARMACEUTICAL HANGZHOU CO LTD · Prescription
Key facts
| Proprietary name | DAUNORUBICIN HYDROCHLORIDE |
|---|---|
| Active ingredients | DAUNORUBICIN HYDROCHLORIDE |
| Strength | EQ 5MG BASE/ML |
| Dosage form | INJECTABLE |
| Route | INJECTION |
| Application | ANDA208759 |
| Applicant holder | HISUN PHARMACEUTICAL HANGZHOU CO LTD |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Apr 12, 2019 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.