Drug application
IBRUTINIB (IBRUTINIB)
Drugs@FDA ANDA 212763 · ALVOGEN PINE BROOK
Key facts
| Drug name | IBRUTINIB |
|---|---|
| Active ingredients | IBRUTINIB |
| Application type | ANDA |
| Application number | 212763 |
| Company | ALVOGEN PINE BROOK |
| Dosage forms | TABLET, ORAL |
| Strength | 140MG |
| Marketing status | None (Tentative Approval) |
| Reference listed drug | No |
| Latest submission status date | Apr 9, 2021 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- No 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: