Orange Book product
IDARUBICIN HYDROCHLORIDE 20MG/20ML (1MG/ML)
Orange Book NDA 050734 · PFIZER INC · Prescription
Key facts
| Proprietary name | IDARUBICIN HYDROCHLORIDE |
|---|---|
| Active ingredients | IDARUBICIN HYDROCHLORIDE |
| Strength | 20MG/20ML (1MG/ML) |
| Dosage form | SOLUTION |
| Route | INTRAVENOUS |
| Application | NDA050734 |
| Applicant holder | PFIZER INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | Yes |
| Approval date | Feb 17, 1997 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- Yes 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.