Orange Book product
TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL
Orange Book ANDA 091089 · FRESENIUS KABI USA LLC · Prescription
Key facts
| Proprietary name | TOPOTECAN HYDROCHLORIDE |
|---|---|
| Active ingredients | TOPOTECAN HYDROCHLORIDE |
| Strength | EQ 4MG BASE/VIAL |
| Dosage form | INJECTABLE |
| Route | INJECTION |
| Application | ANDA091089 |
| Applicant holder | FRESENIUS KABI USA LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Nov 29, 2010 |
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.