Orange Book product
SUNITINIB MALATE EQ 37.5MG BASE
Orange Book ANDA 218024 · NATCO PHARMA LTD · Prescription
Key facts
| Proprietary name | SUNITINIB MALATE |
|---|---|
| Active ingredients | SUNITINIB MALATE |
| Strength | EQ 37.5MG BASE |
| Dosage form | CAPSULE |
| Route | ORAL |
| Application | ANDA218024 |
| Applicant holder | NATCO PHARMA LTD |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Oct 24, 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.