Orange Book product
SUNITINIB MALATE EQ 12.5MG BASE
Orange Book ANDA 218012 · FOSUN WANBANG (JIANGSU) PHARMACEUTICAL GROUP CO LTD · Prescription
Key facts
| Proprietary name | SUNITINIB MALATE |
|---|---|
| Active ingredients | SUNITINIB MALATE |
| Strength | EQ 12.5MG BASE |
| Dosage form | CAPSULE |
| Route | ORAL |
| Application | ANDA218012 |
| Applicant holder | FOSUN WANBANG (JIANGSU) PHARMACEUTICAL GROUP CO LTD |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Aug 21, 2023 |
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.