Drug application
ONTRUZANT (TRASTUZUMAB-DTTB)
Drugs@FDA BLA 761100 · SAMSUNG BIOEPIS CO LTD
Key facts
| Drug name | ONTRUZANT |
|---|---|
| Active ingredients | TRASTUZUMAB-DTTB |
| Application type | BLA |
| Application number | 761100 |
| Company | SAMSUNG BIOEPIS CO LTD |
| Dosage forms | POWDER, IV (INFUSION) |
| Strength | 150MG |
| Marketing status | Prescription |
| Reference listed drug | No |
| Latest submission status date | Jan 18, 2019 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- 1–9 Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- Yes FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: